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 277 Fresenius AquaC UNO H dialysis machines due to misaligned internal ethernet cables that could expose the external port to electrical current, creating a shock risk for service technicians.
Fresenius is recalling 318 AquaC UNO H dialysis machines nationwide due to a potential electrical shock hazard affecting service technicians and operators. An internal ethernet cable may become misaligned, damaging insulation and creating an electrical hazard when the external port is touched.
Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.
Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.
AquaBplus 2000 water purification systems for dialysis have an installation guideline error that may reduce heat disinfection effectiveness. Patients using affected units may be at risk.
Fresenius Medical Care recalled NaturaLyte 2301 dialysate in Texas and Louisiana after exposure to below-recommended storage temperatures. The exposure may cause packaging leaks, potentially leading to biological contamination and bloodstream infection risk.
Fresenius Medical Care is recalling 19 cases of Optiflux 200NRe dialyzers distributed in Pennsylvania after exposure to cold temperatures outside safe storage ranges. Affected lot number is 22AU04017.
The Novalung Sensor Box may experience communication failures between its flow sensor and sensor box component, potentially disabling flow measurement and air bubble detection. The recall affects 115 units distributed across 16 US states.
Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.
Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.
A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.
Fresenius Medical Care recalls Granuflo and Naturalyte hemodialysis concentrate affected by freezing temperatures during refrigerated truck transport. Freezing may compromise product sterility and safety.
Fresenius Medical Care is recalling Citrasate and GranuFlo Dry Acid Concentrates after freezing temperature exposure during refrigerated truck transport. Affected lots distributed in Texas should be discontinued immediately.
Fresenius Medical Care is recalling 5 cases of the APD Luer-Lock Adapter (Lot 20LR08111) distributed in Texas after exposure to freezing temperatures during truck transport. Freezing may have compromised device sterility and functionality.
NaturaLyte Dry Bicarbonate Concentrate, used in hemodialysis machines to prepare dialysate, was recalled after exposure to freezing temperatures during transport. The affected lot (21ATBC004) was distributed to facilities in Texas only.
Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.
Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution, which may compromise sterility or safety.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (Lot #20PU04030, 4 cases) distributed nationwide because the product was exposed to temperatures outside specified limits, which may affect safety and efficacy.
Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.
Fresenius Medical Care is recalling 285 cases of DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide because the product was exposed to temperatures outside specified limits.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.
Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.