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Smiths Medical ASD, Inc. FDA Recalls

161 recalls on file across devices, 71 of them Class I and 140 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
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.Class IApr 10, 2025Pumps may experience Wireless Connection Modules intermitten
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EAClass IApr 10, 2025There is a potential for thermal damage in CADD-Solis and CA
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0Class IApr 10, 2025Affected pumps may trigger an erroneous (false) Upstream Occ
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111Class IApr 10, 2025There is a potential for thermal damage in CADD-Solis and CA
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOClass IApr 10, 2025Affected pumps may trigger an erroneous (false) Upstream Occ
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100Class IIFeb 14, 2025Airway adapter does not meet specification and may break off
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214Class IIFeb 14, 2025Airway adapter does not meet specification and may break off
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.Class IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REClass IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8FClass IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.Class IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6FClass IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035Class IFeb 13, 2025Affected devices have a smaller diameter than expected and m
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9FrClass IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.Class IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24Class IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24Class IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer,Class IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr IntroducerClass IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., RClass IFeb 13, 2025The plastic port housing and port reservoir of the ProPort P
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76Class IIOct 28, 2024Smiths Medical has identified a potential for ingress of flu
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JPClass IIOct 28, 2024Smiths Medical has identified a potential for ingress of flu
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JPClass IIOct 28, 2024Smiths Medical has identified a potential for ingress of flu
medex Arterial Kit 1/EA, Product Code REF MX7827Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504TClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505TClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNTClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530TClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501TClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502TClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFTClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SCClass IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897Class IISep 24, 2024Due to a manufacturing defect, users may experience inaccura
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JSClass IIJul 18, 2024Uncertainty in the seal integrity of the sterile packaging.
smiths medical portex, Y' PIECE 15MM, REF 100/276/000Class IIJul 18, 2024Uncertainty in the seal integrity of the sterile packaging.
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b)Class IIJul 18, 2024Uncertainty in the seal integrity of the sterile packaging.
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/15Class IIJul 18, 2024Uncertainty in the seal integrity of the sterile packaging.
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000Class IIJul 18, 2024Uncertainty in the seal integrity of the sterile packaging.
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD SClass IJul 16, 2024Damage to the battery pack may have caused a short to a capa
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24Class IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28Class IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JPClass IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JPClass IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28Class IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24Class IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CAClass IIJun 26, 2024The adapter input plug can become damaged or broken. If the
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24Class IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24Class IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24Class IIJun 26, 2024Certain CADD Medication Cassette Reservoirs may exhibit a we
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follClass IJun 7, 2024There is the potential for a disconnection of the pilot ball
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, ItemClass IJun 7, 2024There is the potential for a disconnection of the pilot ball
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follClass IJun 7, 2024There is the potential for a disconnection of the pilot ball
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXXClass IMay 31, 2024There is a potential for inadvertent tidal volume knob movem
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310NClass IMay 31, 2024Smiths Medical became aware of an issue related to a potenti
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300NClass IMay 31, 2024Smiths Medical became aware of an issue related to a potenti
Pneupac paraPAC plus 300 ventilator kit, REF P300NXXClass IMay 31, 2024There is a potential for inadvertent tidal volume knob movem
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/LClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHTClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List NClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , ProClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List NClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item CodeClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/LiClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product CodClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Class IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Class IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , ProduClass IMay 29, 2024Smiths Medical has identified that the securement flange of
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60NClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , ProductClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/LClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List NClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , ProClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item CClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO SClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item CClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, ProduClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List NumClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product CodClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/LiClass IMay 29, 2024Smiths Medical has identified that the securement flange of
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item CodClass IMay 29, 2024Smiths Medical has identified that the securement flange of
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, Class IFeb 27, 2024The CADD Solis VIP Ambulatory Infusion Pump is indicated for
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uClass IFeb 27, 2024The CADD Solis VIP Ambulatory Infusion Pump is indicated for
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: IClass IFeb 27, 2024CADD-Solis Ambulatory Infusion Pumps, with software versions
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUSClass IFeb 7, 2024When a paraPAC plus ventilator is switched to the operating
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUSClass IFeb 7, 2024When a paraPAC plus ventilator is switched to the operating
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-5Class IIDec 19, 2023Medfusion Model 4000, 3500, and 3010 pumps manufactured or s
smiths medical Medfusion Model 4000 syringe pumpClass IDec 19, 2023Medfusion Model 4000 syringe infusion pumps, with the follow
smiths medical Medfusion Model 3500 Syringe pumpClass IDec 19, 2023Medfusion syringe pumps, with software versions before v6.0.
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 301Class IIDec 19, 2023Medfusion Model 4000, 3500, and 3010 pumps manufactured or s
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716Class IIDec 19, 2023Medfusion Model 4000, 3500, and 3010 pumps manufactured or s
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0Class IIDec 19, 2023Medfusion Model 4000, 3500, and 3010 pumps manufactured or s
6IN PRESSURE TUBING, List Number MX20617Class IINov 10, 2023There is a manufacturing defect affecting specific rotator l
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694RClass IINov 10, 2023There is a manufacturing defect affecting specific rotator l
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331RClass IINov 10, 2023There is a manufacturing defect affecting specific rotator l
Medex LOGICAL CATH LAB KIT, List Number M20754Class IINov 10, 2023There is a manufacturing defect affecting specific rotator l
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HPClass IINov 10, 2023There is a manufacturing defect affecting specific rotator l
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BRClass IINov 10, 2023There is a manufacturing defect affecting specific rotator l
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682RClass IINov 10, 2023There is a manufacturing defect affecting specific rotator l
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HPClass IINov 10, 2023There is a manufacturing defect affecting specific rotator l
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRLClass IINov 10, 2023There is a manufacturing defect affecting specific rotator l
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1Class IISep 6, 2023The complaint involved the absence of a component called "AS
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.Class IIAug 22, 2023The unit box is labeled with an incorrect expiration date (t
Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pumpClass IIAug 16, 2023A force sensor in the occlusion detector may drift out of ca
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0Class IIAug 16, 2023A force sensor in the occlusion detector may drift out of ca
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pumpClass IIAug 16, 2023A force sensor in the occlusion detector may drift out of ca
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06Class IIAug 16, 2023A force sensor in the occlusion detector may drift out of ca
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6Class IIAug 16, 2023A force sensor in the occlusion detector may drift out of ca
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6Class IIAug 16, 2023A force sensor in the occlusion detector may drift out of ca
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filterClass IIJul 18, 2023Smiths Medical identified a labeling error in which the barc
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction PoClass IIApr 5, 2023DuraLife devices instructions for cleaning and sterilization
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port fClass IIApr 5, 2023DuraLife devices instructions for cleaning and sterilization
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel ElbClass IIApr 5, 2023DuraLife devices instructions for cleaning and sterilization
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP,Class IDec 9, 2022There are two potential issues with CADD Infusion System In
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5)Class IDec 9, 2022There are two potential issues with CADD Infusion System In
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, Class IDec 9, 2022There are two potential issues with CADD Infusion System In
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24Class IDec 9, 2022There are two potential issues with CADD Infusion System In
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, Class IDec 9, 2022There are two potential issues with CADD Infusion System In
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart PumpClass IIOct 10, 2022Potential for delay in sending Infusion Start Messages to th
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 40Class IApr 18, 2022Multiple issues with the potential for interruption of thera
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-8Class IApr 18, 2022Multiple issues with the potential for interruption of thera
Bivona Uncuffed Wire Endotracheal Tubes,Class IIAug 9, 2021Inadequate pouch seal leading to a compromised sterile barri
Bivona Aire-Cuf Endotracheal TubeClass IIAug 9, 2021Inadequate pouch seal leading to a compromised sterile barri
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129Class IAug 6, 2021There is potential for harmful levels of aluminum leaching w
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700Class IAug 6, 2021There is potential for harmful levels of aluminum leaching w
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.Class IIAug 4, 2021The incorrect device is contained in the package.
Pneupac paraPac plus 300 ventilator kit, REF P300NGBClass IIIJul 15, 2021Two devices were labeled with the same serial number
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29GClass IMay 17, 2021Specific models and lot numbers of the Jelco Hypodermic Need
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controllClass IIMay 14, 2021One lot number of a specific model of ULTRAperc Percutaneous
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model NumbeClass IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metClass IIMar 31, 2021The firm became aware via complaints that one lot of ACE MDI
Left Heart Kit, Model Number M20268. for blood pressure monitoring.Class IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.Class IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to contrClass IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure TransduceClass IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.Class IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLDClass IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchialClass IIMar 31, 2021The firm became aware via complaints that one lot of ACE MDI
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the directioClass IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.Class IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.Class IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOClass IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravasculClass IIMar 31, 2021Specific lots of Medex High Pressure Adaptors, Rotators, Man
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 39Class IIJan 18, 2021Smiths Medical became aware that three lot numbers of a spec

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