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Baxter Healthcare Corporation FDA Recalls

326 recalls on file across devices, drugs, 68 of them Class I and 278 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and outpuClass IIAug 18, 2026There is an error in the product description on the Unique D
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and outpuClass IIAug 18, 2026There is an error in the product description on the Unique D
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intakeClass IIAug 18, 2026There is an error in the product description on the Unique D
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare CorporaClass IAug 17, 2026Presence of particulate matter: Particulates identified as f
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NClass IAug 17, 2026Presence of Particulate Matter: particulate matter identifie
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSClass IIAug 11, 2026A software issue that may occur during a Volume/Time (VOT) m
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLClass IIAug 11, 2026A software issue that may occur during a Volume/Time (VOT) m
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare CorClass IIAug 6, 2026CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, StClass IIAug 6, 2026CGMP Deviations
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose ContainerClass IIAug 6, 2026CGMP Deviations
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXClass IIAug 6, 2026CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, SteriClass IIAug 6, 2026CGMP Deviations
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose CoClass IIAug 6, 2026CGMP Deviations
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Class IIAug 6, 2026CGMP Deviations
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile NonpyrClass IIAug 6, 2026CGMP Deviations
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile NonClass IIAug 6, 2026CGMP Deviations
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx onlyClass IIAug 6, 2026CGMP Deviations
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single DClass IIAug 6, 2026CGMP Deviations
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx onlyClass IIAug 6, 2026CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, StClass IIAug 6, 2026CGMP Deviations
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, StClass IIAug 6, 2026CGMP Deviations
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY ContainerClass IIAug 6, 2026CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, SteriClass IIAug 6, 2026CGMP Deviations
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotiClass IIAug 6, 2026CGMP Deviations
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A ProductClass IIAug 3, 2026Contamination within the release test equipment flow path co
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic ContainerClass IJul 24, 2026Presence of Particulate Matter
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration SetsClass IJun 30, 2026Baxter received customer reports of air bubbles in the drip
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung ExpClass IMay 21, 2026There have been reports of air and medication leakage from t
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung ExpaClass IMay 21, 2026There have been reports of air and medication leakage from t
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung EClass IMay 21, 2026There have been reports of air and medication leakage from t
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation LungClass IMay 21, 2026There have been reports of air and medication leakage from t
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Class IIApr 22, 2026Affected lots may contain incorrect 0.8-micron filters. Use
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper BClass IIApr 21, 2026The Adapter for Head Positioning accessory may become loose
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara RespiratoryClass IFeb 18, 2026Urgent Medical Device Correction for the Volara system singl
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 SoftwaClass IIFeb 18, 2026Display screen may unintentionally flicker due to a software
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product DescClass IIJan 13, 2026Pumps were released without full testing being performed, in
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 6Class IIDec 22, 2025Presence of particulate matter: plastic particles from the b
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2Class IINov 28, 2025Certain pumps have potentially been released from service wi
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn TClass IIOct 28, 2025Replacement bladder kit for the Welch Allyn two-piece reusab
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 0169Class IISep 17, 2025Affected oral/axillary probes were inadvertently programmed
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, RetractableClass IIAug 29, 2025IV sets may leak.
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 MicroClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/Class IIAug 29, 2025IV sets may leak.
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock ExtensioClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519Class IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Class IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), ProdClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, BackcheckClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, BackcheClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, RetractabClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, RetractableClass IIAug 29, 2025IV sets may leak.
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK LuerClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mLClass IIAug 29, 2025IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, RetractabClass IIAug 29, 2025IV sets may leak.
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product codeClass IIAug 29, 2025IV sets may leak.
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare CorpoClass IIAug 20, 2025Discoloration
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 Class IIAug 8, 2025Baxter Healthcare Corporation is issuing an Urgent Medical D
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pumpClass IAug 4, 2025Baxter Healthcare Corporation is issuing an Urgent Medical D
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pumpClass IAug 4, 2025Baxter Healthcare Corporation is issuing an Urgent Medical D
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pumpClass IAug 4, 2025Baxter Healthcare Corporation is issuing an Urgent Medical D
Spectrum IQ Infusion Pump, Product Code 3570009Class IIJul 14, 2025Baxter has identified that certain pumps have potentially be
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUSClass IJul 14, 2025Baxter is issuing an Urgent Medical Device Correction for th
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2Class IJun 20, 2025Certain Spectrum infusion pumps may have an incorrect versio
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAXClass IJun 20, 2025Certain Spectrum infusion pumps may have an incorrect versio
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScClass IMay 30, 2025The Q-link 13 could allow for an improper attachment (false
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE MobileClass IMay 30, 2025The Q-link 13 could allow for an improper attachment (false
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,Class IIMay 12, 2025Baxter has identified a design issue which may cause the pum
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600Class IIMay 9, 2025The replacement rechargeable batteries inserted into the Wel
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043Class IIMay 6, 2025There is a potential for improper crimps on the signal wires
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUSClass IApr 24, 2025There is a potential for the Novum IQ LVP due to the potenti
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; Class IApr 7, 2025A cybersecurity vulnerability was discovered through interna
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT20Class IApr 7, 2025A cybersecurity vulnerability was discovered through interna
Welch Allyn CONNEX Accessory Power Management Stand:Class IIMar 24, 2025There were customer reports of devices which experienced bat
Welch Allyn CP150 Electrocardiograph:Class IIMar 24, 2025There were customer reports of devices which experienced bat
Welch Allyn Connex Vital Signs Monitor (CVSM):Class IIMar 24, 2025There were customer reports of devices which experienced bat
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6Class IIMar 21, 2025Undeclared natural rubber band within the packaging of certa
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74Class IIMar 21, 2025Undeclared natural rubber band within the packaging of certa
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure CuffClass IIMar 21, 2025Undeclared natural rubber band within the packaging of certa
Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; Class IIMar 21, 2025Undeclared natural rubber band within the packaging of certa
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK AneClass IIMar 21, 2025Undeclared natural rubber band within the packaging of certa
Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MClass IIMar 21, 2025Undeclared natural rubber band within the packaging of certa
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) PrClass IIMar 21, 2025Undeclared natural rubber band within the packaging of certa
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUSClass IIMar 3, 2025Baxter Healthcare Corporation is issuing an Urgent Medical D
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobilClass IIFeb 25, 2025The air bladders inside the mattress may move out of positio
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Floor mounting column TruSystem 7500, Product Code 1717021Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Stationary column TruSystem 7500 U, Product Code 1730731Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Mobile column TruSystem 7500, Product Code 1717023Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Stationary column TruSystem 7500, Product Code 1717020Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter TruSystem 7500, Product Code 4091000Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Floor mounting column TS 7500 U, Product Code 1730732Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Mobile column TruSystem 7500 U, Product Code 1730720Class IIFeb 25, 2025There is a software issue which causes the upper back sectio
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009Class IFeb 5, 2025There is the potential for missing motor mounting screws, wh
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAXClass IFeb 5, 2025There is the potential for missing motor mounting screws, wh
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AClass IDec 20, 2024There is an issue with the ventilator battery charger that c
Baxter Solution Set with Duo-Vent Spike, REF 2R8404Class IIDec 20, 2024Specific lots of Solution Sets with Duo-Vent Spike have the
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519Class IIDec 20, 2024Specific lots of Solution Sets with Duo-Vent Spike have the
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002APClass IDec 20, 2024There is an issue with the ventilator battery charger that c
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002Class IDec 20, 2024There is an issue with the ventilator battery charger that c
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538Class IIDec 20, 2024Specific lots of Solution Sets with Duo-Vent Spike have the
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002APClass IDec 20, 2024There is an issue with the ventilator battery charger that c
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2Class IINov 19, 2024Devices were identified as released after repair without ful
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAXClass IINov 19, 2024Devices were identified as released after repair without ful
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter PhClass IIOct 30, 2024Labeling: Missing Label
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal DialyClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal DialysClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal DialysisClass IIOct 23, 2024There has been an increase in the number of complaints relat
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal DialysisClass IOct 21, 2024Baxter is aware of several recalls by other manufacturers re
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name isClass IOct 16, 2024Baxter is aware of several recalls by other manufacturers re
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; ElectrocardiographClass IIOct 11, 2024There is the potential for exam files being assigned duplica
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoringClass IIOct 11, 2024There is the potential for exam files being assigned duplica
Hillrom Welch Allyn Vision Express Holter Analysis System; ElectrocardiographClass IIOct 11, 2024There is the potential for exam files being assigned duplica
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress testClass IIOct 11, 2024There is the potential for exam files being assigned duplica
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometerClass IIOct 11, 2024There is the potential for exam files being assigned duplica
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic ComputerClass IIOct 11, 2024There is the potential for exam files being assigned duplica
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009Class IIOct 2, 2024The door on the Spectrum IQ Infusion pump may not be able to
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000, Product code REF 1841046Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049Class IISep 19, 2024The firm received customer reports stating that the batterie
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083Class IISep 19, 2024The firm received customer reports stating that the batterie
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7Class IISep 18, 2024The beds have a potential for an interface issue with the Ra
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3Class ISep 12, 2024The Life2000 ventilator may fail to initiate the Low Gas Pre
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding deviceClass IAug 20, 2024Baxter Healthcare Corporation has received increased custome
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding deviceClass IAug 20, 2024Baxter Healthcare Corporation has received increased custome
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding deviceClass IAug 20, 2024Baxter Healthcare Corporation has received increased custome
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding deviceClass IAug 20, 2024Baxter Healthcare Corporation has received increased custome
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile SinglClass IAug 1, 2024Microbial Contamination of Sterile Products; out of limit re
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (SpeClass IIJul 17, 2024The Spectrum WBM may fail to auto-document infusion status i
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 Class IIJul 17, 2024The Spectrum WBM may fail to auto-document infusion status i
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300Class IIJun 28, 2024Baxter Healthcare Corporation is issuing an Urgent Medical D
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration OnlyClass IIJun 17, 2024Lack of Assurance of Sterility: Potential presence of leaks
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2Class IIJun 14, 2024Improperly performed testing prior to release
Braun Thermoscan¿ PRO 6000 Ear ThermometerClass IIJun 13, 2024The Braun Thermoscan PRO 6000 ear thermometers may have been
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Class IIJun 4, 2024Baxter Healthcare Corporation is issuing an Urgent Medical D
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b)Class IIJun 4, 2024Baxter Healthcare Corporation is issuing an Urgent Medical D
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical LighClass IIJun 4, 2024Baxter Healthcare Corporation is issuing an Urgent Medical D
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one ofClass IIJun 3, 2024During manufacturing, the step to install an Electromagnetic
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. InClass IMay 30, 2024Potential of the handset plug to disconnect from the nebuliz
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.Class IMay 30, 2024Potential of the handset plug to disconnect from the nebuliz
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes Class IMay 29, 2024Potential for certain Life2000 ventilator systems to either
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to pClass IIMay 8, 2024There is a potential for the top cover of the hospital bed m
Spectrum IQ Infusion pump, Product Code 357009Class IIApr 9, 2024There is a potential for cracks on the mount of the front pa
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASSClass IIMar 26, 2024Baxter received reports of an issue related to the construct
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 34Class IIMar 26, 2024Baxter received reports of an issue related to the construct
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASEClass IIMar 26, 2024Baxter received reports of an issue related to the construct
Baxter Spectrum IQ Infusion Pump, Product Code 3570009Class IIMar 20, 2024One device was improperly performed testing prior to release
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgeryClass IIMar 15, 2024Product was distributed in the United States without proper
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's fClass IIMar 11, 2024Baxter Healthcare Corporation is issuing an Urgent Medical D
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention anClass IIMar 5, 2024Inconsistencies were identified with service records associa
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIClass IIFeb 28, 2024A new contraindication was added to the IFU which states tha
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e)Class IIFeb 28, 2024A new contraindication was added to the IFU which states tha
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d)Class IIFeb 28, 2024A new contraindication was added to the IFU which states tha
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225Class IIFeb 28, 2024A new contraindication was added to the IFU which states tha
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools BrochClass IIFeb 22, 2024The Surgical Tools and Cardiovascular Specialty marketing br
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools BrochClass IIFeb 22, 2024The Surgical Tools and Cardiovascular Specialty marketing br
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools BrochClass IIFeb 22, 2024The Surgical Tools and Cardiovascular Specialty marketing br
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192Class IIFeb 14, 2024Three lots of the Boot Assembly, Traction Device are being r
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401Class IIFeb 8, 2024Baxter Healthcare Corporation is issuing an Urgent Medical D
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vialClass IIJan 23, 2024Incorrect product concentration on the overwrap label: The o
Baxter Exactamix Pro 2400, REF EXM24DYClass IDec 22, 2023An error was identified in software versions 2.0.8 and 2.1.8
Baxter Exactamix Pro 1200, REF EXM12DYClass IDec 22, 2023An error was identified in software versions 2.0.8 and 2.1.8
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QClass IIDec 8, 2023Potential distortion identified in electrocardiogram (ECG) r
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USClass IIDec 8, 2023Potential distortion identified in electrocardiogram (ECG) r
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AClass IIDec 8, 2023Potential distortion identified in electrocardiogram (ECG) r
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 Class IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.Class IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL USClass IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 GClass IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMClass IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072Class IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mLClass IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883Class IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MClass IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808Class IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4Class IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c)Class IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GClass IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TClass IIDec 6, 2023Cardiovascular Surgery marketing brochure (US-AS46-220001) t
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479Class IINov 15, 2023There is to an increase in complaints related to failure ala
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare CorporationClass IINov 14, 2023Failed pH Specifications
Novum IQ Syringe infusion system, Product Code 40800BAXUSClass IOct 13, 2023Baxter is issuing an Urgent Medical Device Correction for th
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A0000Class IIOct 4, 2023Progressa+ beds have the potential for static buildup from t
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured fClass IIAug 24, 2023CGMP Deviations: Product was exposed to temperatures exceedi
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter HealthcarClass IIIAug 14, 2023Labeling: Missing Label; customer complaint received that la
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II ContaineClass IIAug 11, 2023Lack of Assurance of Sterility: Potential presence of leaks
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx OClass IIAug 11, 2023Lack of Assurance of Sterility: Potential presence of leaks
Welch Allyn Connex Spot MonitorClass IIAug 10, 2023Product is being recalled due to the improper placement of a
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.Class IIAug 10, 2023Epiphany, now a Baxter Healthcare company, is issuing an Urg
GEM FLOW COUPLER Monitor, PN 5156-00000-011Class IIJun 19, 2023An issue was identified where the LCD monitor display may no
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2Class IJun 15, 2023A medical device correction is being issued for SIGMA Spectr
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009Class IJun 15, 2023A medical device correction is being issued for SIGMA Spectr
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella BedClass IIMay 19, 2023Baxter identified a potential risk where the "safety" monito
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella BedClass IIMay 19, 2023Baxter identified a potential risk where the "safety" monito
Allen Advance Chest Support with PadClass IIMay 18, 2023Potential for the device to crack where the Chest Base Prone
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 2Class IIMar 31, 2023There is a potential for mattress cover damage (delamination
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; forClass IIMar 27, 2023The product is brittle and potentially crumbling upon handli
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringeClass IIMar 20, 2023ExataMed 20 mL oral dispenser component of the Clear Pharmac
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter HeClass IIMar 15, 2023Lack of Assurance of Sterility: Potential presence of leaks
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex IIClass IIMar 15, 2023Lack of Assurance of Sterility: Potential presence of leaks
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.Class IIFeb 22, 2023The electrical safety testing was not properly performed on
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for perClass IIFeb 1, 2023MiniCap Disconnect Cap with Povidone-Iodine are packaged in
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individualsClass IJan 25, 2023There is the potential for patient desaturation events to oc
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individualsClass IJan 25, 2023There is the potential for patient desaturation events to oc
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individualsClass IJan 25, 2023There is the potential for patient desaturation events to oc
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individualsClass IJan 25, 2023There is the potential for patient desaturation events to oc
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal faClass IINov 23, 2022Potential for Internal Blood Leaks due to a twisted gasket i
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.Class IINov 23, 2022Reports of Polyurethane Displacement in the dialyzer, and mi
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.Class IINov 23, 2022Reports of Polyurethane Displacement in the dialyzer, and mi
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.Class IINov 23, 2022Potential for Internal Blood Leaks due to a twisted gasket i
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.Class IINov 23, 2022Reports of Polyurethane Displacement in the dialyzer, and mi
Baxter Electrocardiograph, ELI 380 -DCS21Class IIOct 31, 2022One ELI 380 Electrocardiograph intended to be used for a pil
Hill-Rom Progressa Bed SystemClass IIOct 18, 2022The compression links on impacted Progressa beds, listed in
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P0Class ISep 30, 2022Radio frequency emission from a functioning WatchCare device
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Class ISep 30, 2022Radio frequency emission from a functioning WatchCare device
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part NumClass ISep 30, 2022Radio frequency emission from a functioning WatchCare device
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P0Class ISep 30, 2022Radio frequency emission from a functioning WatchCare device
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, Class ISep 30, 2022Radio frequency emission from a functioning WatchCare device
Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Class IISep 20, 2022the adhesive, applied to screws and bolts as an additional h
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,Class IISep 20, 2022the adhesive, applied to screws and bolts as an additional h
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to positionClass IISep 20, 2022the adhesive, applied to screws and bolts as an additional h
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distraClass IISep 20, 2022the adhesive, applied to screws and bolts as an additional h
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patClass IISep 20, 2022the adhesive, applied to screws and bolts as an additional h
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room tableClass IISep 20, 2022the adhesive, applied to screws and bolts as an additional h
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid managemClass IISep 14, 2022Within the current Prismaflex set IFU (instructions for use)
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement tClass IISep 14, 2022Within the current Prismaflex set IFU (instructions for use)
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid mClass IISep 14, 2022Within the current Prismaflex set IFU (instructions for use)
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in prClass IISep 14, 2022Within the current Prismaflex set IFU (instructions for use)
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement theraClass IISep 14, 2022Within the current Prismaflex set IFU (instructions for use)
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spClass IIISep 2, 2022Labeling has incorrect or incomplete Unique Device Identific
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.Class IAug 9, 2022Firm noted an increase in customer reports of leaks.
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Class IIAug 4, 2022Temperature Abuse: Product distributed in refrigerated truck
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100Class IIJul 22, 2022There is a potential of the packaging not maintaining a ster
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100Class IIJul 22, 2022There is a potential of the packaging not maintaining a ster
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673Class IIJul 22, 2022There is a potential of the packaging not maintaining a ster
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100Class IIJul 22, 2022There is a potential of the packaging not maintaining a ster
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100Class IIJul 22, 2022There is a potential of the packaging not maintaining a ster
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100Class IIJul 22, 2022There is a potential of the packaging not maintaining a ster
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100Class IIJul 22, 2022There is a potential of the packaging not maintaining a ster
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in tClass IIJul 14, 2022There is a potential for leaking valves on ports 1 to 4 in c
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-RClass IIJun 24, 2022The failure mode on the affected mattresses can cause a redu
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.Class IIJun 24, 2022The failure mode on the affected mattresses can cause a redu
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.Class IIJun 24, 2022The failure mode on the affected mattresses can cause a redu
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.Class IIJun 24, 2022The failure mode on the affected mattresses can cause a redu
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.Class IIJun 24, 2022The failure mode on the affected mattresses can cause a redu
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.Class IIJun 24, 2022The failure mode on the affected mattresses can cause a redu
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.Class IIJun 24, 2022The failure mode on the affected mattresses can cause a redu
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (AbaClass IJun 22, 2022There is a potential risk of medication error when using spe
NaviCare Nurse Call/Voalte Nurse CallClass IIMay 31, 2022An issue has been identified with Phillips (Emergin) and Lon
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LEDClass IIMay 17, 2022Packaging error.
In-Line ventilator adaptorClass IApr 26, 2022There is a potential of reduced oxygenation or pneumothorax/
In-Line ventilator adaptorClass IApr 26, 2022There is a potential of reduced oxygenation or pneumothorax/
15 Liters Drain BagClass IIApr 21, 2022Certain Peritoneal Dialysis product codes do not have FDA re
Locking Cap for PD Catheter AdapterClass IIApr 21, 2022Certain Peritoneal Dialysis product codes do not have FDA re
Effluent Sample BagClass IIApr 21, 2022Certain Peritoneal Dialysis product codes do not have FDA re
3,65 m Extension Set with Luer-lock ConnectorClass IIApr 21, 2022Certain Peritoneal Dialysis product codes do not have FDA re
5 Prong Manifold Set (with Luer Connectors)Class IIApr 21, 2022Certain Peritoneal Dialysis product codes do not have FDA re
APD Drain ManifoldClass IIApr 21, 2022Certain Peritoneal Dialysis product codes do not have FDA re
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staClass IIApr 13, 2022Firm discovered a firmware memory leak with a supplier-manuf
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, sClass IIApr 13, 2022Firm discovered a firmware memory leak with a supplier-manuf
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastClass IIApr 1, 2022There is a potential for foreign matter.
PrisMax System, Product Code 955626Class IIMar 15, 2022This correction is due to software anomalies occurring durin
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701Class IIMar 15, 2022This correction is due to software anomalies occurring durin
PrisMax System, Product Code 955724Class IIMar 15, 2022This correction is due to software anomalies occurring durin
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484Class IIFeb 25, 2022Devices distributed lacked regulatory clearance.
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.Class IIFeb 25, 2022Product is mislabeled as self-righting Luer slip tip caps, y
Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and PClass IIFeb 21, 2022An incorrect center bolt was used in the assembly of the pro
Compella Therapy Air Supply UnitClass IIFeb 14, 2022Potential damage to the power cord may cause the power condu
Compella Bariatric Bed SystemClass IIFeb 14, 2022Potential damage to the power cord may cause the power condu
Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482EClass IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482SClass IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJClass IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449Class IIJan 7, 2022Cleaning products, containing, but not limited to, hydrogen
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.Class IDec 29, 2021There is the potential for reduced or non-delivery of medica
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.Class IDec 29, 2021There is the potential for reduced or non-delivery of medica
Hemodialysis Delivery System, Software Version 2.x.Class IISep 29, 2021If the operator initiates therapy with a saved prescription
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) dClass IIJul 22, 2021Products labeled as sterile were distributed, but may not ha
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous flClass IIJul 22, 2021Products labeled as sterile were distributed, but may not ha
Dose IQ Safety Software used with Spectrum IQ Infusion PumpClass IJul 7, 2021Software issue: The defect creates a mismatch between linke
Kaguya Automated Peritoneal Dialysis SystemClass IIJun 30, 2021Baxter Healthcare Corporation has identified that the AMIA S
Sharesource Connectivity Platform for Use with the Amia Automated PD SystemClass IIJun 30, 2021Baxter Healthcare Corporation has identified that the AMIA S
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.Class IIJun 15, 2021There is a discrepancy in the expiry date encoded into the 2
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of flClass IJun 4, 2021System errors were noted following changes the customers imp
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment usiClass IIApr 14, 2021There is a potential leak between the venous patient connect
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.Class IIMar 19, 2021Potentially defective component in the AC power adapter whic
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).Class IIJan 28, 2021Variability in the performance of the tubing in the Prismafl
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).Class IIJan 28, 2021Variability in the performance of the tubing in the Prismafl
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex ContClass IIJan 28, 2021Variability in the performance of the tubing in the Prismafl
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).Class IIJan 28, 2021Variability in the performance of the tubing in the Prismafl
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tClass IIJan 7, 2021Variability in the performance of the tubing in the ARPS (Au
Infusion PumpClass IIJan 6, 2021Battery performance issues related to prolonged storage.

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