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Fresenius Medical Care Holdings, Inc. FDA Recalls
79 recalls on file across devices, drugs, 16 of them Class I and 57 still open. Matched by name to FMS.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;Class IIMay 12, 2026Given the increased number of leaks reported by users, it w |
| 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush SClass IIMay 11, 2026Potential for Online Port Errors due to connection issues wh |
| Bicarby Dialysate; Model number: RFP-400-G;Class IIMay 7, 2026There is an error in the labeling of the GTIN on the product |
| DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, Class IIApr 6, 2026Lack of Assurance of Sterility: Potential leaks from perfora |
| DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2Class IIApr 6, 2026Lack of Assurance of Sterility: Potential leaks from perfora |
| 5008X CAREsystem +CLiC +CDX;Class IIOct 25, 2025Several software anomalies with the potential to impact pati |
| Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLClass IIAug 29, 2025To provide further information to the user to ensure proper |
| 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, Class IIMay 27, 2025Lack of Assurance of Sterility |
| 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,Class IIApr 29, 2025Potential of blood leak occurring between the lower port of |
| Dialyzer Optiflux 160NReClass IIDec 5, 2024Potential for internal blood leaks due to cracked polyuretha |
| Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 SClass IIAug 8, 2024Machines equipped with BPM3 Blood Pressure Modules (Blood pr |
| DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange SeClass IIJun 18, 2024This product is being recalled due to the tube weld failure |
| RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev AClass IIJun 3, 2024An increased number of complaints were reported on the Blood |
| US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:Class IIMay 16, 2024Concentrate Flow was exceeding the maximum 19.9 bar set poin |
| Blood Pump Rotor, Model Number: F40015481 Rev AClass IIApr 17, 2024An increased number of complaints were reported on the Blood |
| 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.Class IIApr 17, 2024An increased number of complaints were reported on the Blood |
| 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.Class IIApr 17, 2024An increased number of complaints were reported on the Blood |
| 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.Class IIApr 17, 2024An increased number of complaints were reported on the Blood |
| 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev AClass IIApr 17, 2024An increased number of complaints were reported on the Blood |
| Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ Class IIApr 8, 2024Issue related to Novalung sensor box, which is a component o |
| stay-safe /Luer Lock Catheter Ext. 12 inClass IJan 23, 2024The peroxide cross-linked tubing has leachables identified a |
| stay-safe /Luer Catheter Ext. 6 inClass IJan 23, 2024The peroxide cross-linked tubing has leachables identified a |
| stay-safe /Luer Lock Catheter Ext. 18 inClass IJan 23, 2024The peroxide cross-linked tubing has leachables identified a |
| stay-safe /Safe Lock Catheter Ext. 12 inClass IJan 23, 2024The peroxide cross-linked tubing has leachables identified a |
| stay-safe /Luer Lock Adapter 4 inClass IJan 23, 2024The peroxide cross-linked tubing has leachables identified a |
| DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius MedClass IIDec 28, 2023Lack of Sterility Assurance |
| Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111Class IIIOct 24, 2023Affected Liberty Select cyclers may display an incorrect tim |
| Stay Safe CapClass IIOct 10, 2023Updating the labeling to include additional warnings and con |
| 2008T HD SYS. CDX BLUESTARClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 2008T HD SYS. W/O CDX W/BIBAG BLUESTARClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 2008T Hemodialysis System without CDXClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 2008T HD SYS. W/O CDX BLUESTARClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 2008T Hemodialysis SYS, with CDXClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 2008T Hemodialysis System w/BibagClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 2008T HD SYS. CDX W/BIBAG BLUESTARClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 2008T GEN 2 Bibag without CDXClass ISep 6, 2023Potential PCBA leaching from tubing of hemodialysis machines |
| 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per caseClass IAug 8, 2023There is a potential for blood backfill leakage and foreign |
| 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a caseClass IAug 8, 2023There is a potential for blood backfill leakage and foreign |
| 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per caseClass IAug 8, 2023There is a potential for blood backfill leakage and foreign |
| Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, WaClass IIMay 23, 2023Lack of assurance of sterility: The product was potentially |
| 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,Class IINov 22, 2022Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chlor |
| 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,Class IIOct 11, 2022Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chlor |
| NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.Class IIOct 4, 2022The "Nominal Chemical Composition" section of the label inco |
| 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcareClass IIJul 27, 2022(1)Software version 2.74 upgrade and (2)hardware related cau |
| AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. FresenClass IIJun 21, 2022Internal ethemet cables are missing one or both ferrite core |
| AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. FreClass IIJun 21, 2022Internal ethemet cables are missing one or both ferrite core |
| AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-USClass IIJun 16, 2022Internal ethernet cable may be misaligned, the cable jacket |
| AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-USClass IIJun 16, 2022Internal ethernet cable may be misaligned, the cable jacket |
| NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3Class IIJun 1, 2022The product was potentially exposed to below-recommended sto |
| NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for Class IIMay 31, 2022Alternate Bottle Caps labeled with "Sealed for your Protecti |
| NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for Class IIMay 31, 2022Alternate Bottle Caps labeled with "Sealed for your Protecti |
| Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320EClass IIMay 4, 2022Dialyzers were distributed after being exposed to cold tempe |
| Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respirClass IIDec 7, 2021Error messages 206 (yellow) and 208 (red) technical failure, |
| AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - TyClass IIAug 3, 2021AquaBplus HF module on the AquaBplus 2000 osmosis system, an |
| DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange setClass IIIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49Class IIIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, WalthClass IIIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients witClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the prepClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component iClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10Class IIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivaClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the prClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDClass IIIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, WClass IIIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set,Class IIIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equippedClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle duringClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set,Class IIIApr 28, 2021Temperature Abuse: Product exposed to temperature outside sp |
| 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in hClass IIApr 28, 2021Exposed to freezing temperatures due to refrigerated truck m |
| AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remClass IIMar 18, 2021AquaBplus HF module on the AquaBplus 2500 osmosis system, an |