Manufacturer
75 recalls in our database name Fresenius Medical Care Holdings, Inc. as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
The FDA is recalling approximately 828,954 stay-safe Luer Lock Adapters due to chemical leachables identified in the peroxide cross-linked tubing. The nationwide recall affects all lots of Model Number 050-95003.
Fresenius is recalling 479,978 stay-safe Luer Lock Catheter Extensions due to chemical leachables in the tubing. Healthcare providers should contact the manufacturer for replacement information.
Fresenius Medical Care is recalling 105,700 stay-safe /Luer Catheter Extension 6 in devices nationwide due to chemical leachables identified in the peroxide cross-linked tubing. FDA classified this as a Class I recall.
Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.
Fresenius Medical Care is recalling 69,590 bags of DELFLEX Peritoneal Dialysis Solution due to lack of sterility assurance. The affected lot was distributed nationwide.
Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.
Fresenius Medical Care is updating the Stay Safe Cap's labeling to include additional warnings and contraindications for potential side effects. No illnesses have been reported.
Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.
Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.
Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.
Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.
Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.
Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.
Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.
Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.
Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.
Fresenius Medical Care is recalling Sodium Chloride 0.9% Injection due to potential storage temperature exposure that may compromise sterility. The affected product includes 53,424 bags distributed to clinics in South Carolina, North Carolina, and Virginia.
Fresenius Medical Care is recalling 2008T and 2008T Bluestar Hemodialysis Machines with CDX due to a software and hardware sensitivity to electromagnetic interference that triggers false alarms.
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection due to lack of sterility assurance from potential leakage. The nationwide recall affects injectable saline bags distributed in the United States.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection distributed nationwide due to lack of assurance of sterility and potential leakage. Multiple lot numbers with expiration dates ranging from May 2023 to August 2023 are affected.
Fresenius is recalling 24 units of the AquaC UNO H reverse osmosis unit because internal ethernet cables lack ferrite cores, compromising electromagnetic compatibility in hemodialysis water purification systems.
Fresenius is recalling 6 units of the AquaC UNO H reverse osmosis unit used with hemodialysis systems due to missing ferrite cores in internal ethernet cables affecting electromagnetic compatibility.