Every recall we track for Fresenius Medical Care Holdings, Inc. — 117 in all — plus the complaints and injury reports the public filed about them.
Fresenius Medical Care recalls Bicarby dialysate models RFP-400-G to RFP-456-G due to potential leaks causing slip and fall hazards. Affected units were produced from January 2025 to January 2026.
Fresenius Medical Care recalls 5008X Blood Tubing Sets with potential online port errors when connecting SafeLine to substitution fluid port. Affected units include specific model numbers and lots manufactured after February 26, 2026.
Fresenius Medical Care recalls Bicarby Dialysate model RFP-400-G due to incorrect GTIN labeling that may lead to wrong potassium solution use. Affected units have specific lot codes.
Fresenius Medical Care recalls DELFLEX peritoneal dialysis solution with attached exchange set due to potential leaks from bag perforations. Affected lots 25CU02007-02009.
Fresenius Medical Care recalls DELFLEX peritoneal dialysis solution with possible bag leaks due to perforations. Affected lots: 25CU02002, 25CU02011, 25CU02012, 25CU02013. Stop using immediately if you have this product.
Fresenius Medical Care recalls 5008X CAREsystem devices with software versions before 4.82.4 due to potential treatment stop risks. Affected units may require software updates to prevent patient treatment interruptions.
Fresenius Medical Care recalls Optiflux High Flux E-beam Dialyzers with press-on caps that may not secure properly. Affected models were manufactured after September 6, 2023. No remedy specified in recall notice.
Fresenius Medical Care recalls 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected units have specific NDC codes and expiration dates. Consumers should stop using and contact the company for details.
Recall of 5008X HDF Hemodialysis Blood Tubing Sets with potential blood leaks during hemodialysis procedures. Affected models include 03-5100-7 and variants. Contact manufacturer for details.
Fresenius Medical Care recalls Dialyzer Optiflux 160NRe dialyzers with potential internal blood leaks due to cracked polyurethane. Affected units have specific UDI numbers and expire June 30, 2027.
Fresenius Medical Care is a leading global provider of medical devices and healthcare solutions, including dialysis machines, infusion systems, and more.
Fresenius Medical Care recalls 2008K@HOME HEMODIALYSIS SYSTEM Blood Pump Rotor spare part (Model F40015481 Rev A) due to loose/dislodged guide sheaves reported by clinics. Affected units have specific serial numbers and model identifiers.
Fresenius Medical Care recalls 2008K@HOME HD System blood pump rotor spare part (model F40015481 Rev A) due to loose guide sheaves reported by clinics. Affected units have specific serial numbers in Canada.
Fresenius Medical Care recalls 2008K@HOME HEMODIALYSIS SYSTEM spare parts with loose guide sheaves. Affected units have model F40015481 Rev A and serial numbers starting with 5K0S.
Fresenius Medical Care recalls 2008K@HOME HEMODIALYSIS SYSTEM Blood Pump Rotor spare part (Model F40015481 Rev A) due to reported loose/dislodged guide sheaves in clinics after use. 190828 units affected.
Fresenius Medical Care recalls 190395 blood pump rotor spare parts (model F40015481 Rev A) due to reported loose/dislodged guide sheaves in clinics. Affected units have specific serial numbers listed in the recall notice.
Recall of 2008K@HOME HEMODIALYSIS SYSTEM with Blood Pump Rotor spare part (Model F40015481 Rev A) due to loose/dislodged guide sheaves reported by clinics.
Fresenius Medical Care recalls blood pump rotor spare parts (model F40015481 Rev A) due to reported loose guide sheaves in clinics. Affected units include specific serial numbers and refurbished rental models.
Fresenius Medical recalls blood pump rotor spare parts (Model F40015481 Rev A) due to reported loose/dislodged guide sheaves in clinics. Affected units have specific serial numbers and model identifiers.
Fresenius recalls US AquaA 900H-Typ USA-3 hemodialysis water purifiers due to concentrate pressure exceeding safe limits, causing dialysis interruptions. Affected units have specific serial numbers and part numbers.
Fresenius Medical Care is a leading global provider of blood purification systems and related products. We offer innovative solutions for hemodialysis, peritoneal dialysis, and other critical care applications.
Recall of 2008T BlueStar Hemodialysis Machines (Model 191124) with Blood Pump Rotor (P/N F40015481 Rev A) due to loose guide sheaves reported by clinics. Affected units have specific serial numbers listed.
Recall of 2008T BlueStar Hemodialysis Machine Model 191128 with Blood Pump Rotor Model F40015481 Rev A due to loose guide sheaves after use. Affected units have specific serial numbers.
Fresenius Medical Care is a leading global provider of medical devices and healthcare solutions. We offer a wide range of products for various medical applications.
Fresenius Medical Care recalls Blood Pump Rotor model F40015481 Rev A due to reported loose guide sheaves causing potential dislodgement in clinical use. Affected units may need inspection or replacement.
Fresenius Medical Care recalls Novalung sensor boxes (F30000163) that may show error messages #206 or #208 during use, potentially indicating technical failure in long-term respiratory support systems.
Fresenius Medical Care recalls Safe Lock Catheter Extension 12 in due to potential leachables in tubing. Affected units have specific model and lot numbers. Consumers should contact for details.
Fresenius Medical Care recalls Stay-Safe Luer Catheter Ext 6 in due to potential leachables in tubing. Affected units have specific model and lot numbers.
Fresenius Medical Care recalls Stay-Safe Luer Lock Catheter Ext 18 in due to potential leachables in tubing. Affected units have specific model and lot numbers. Consumers should contact the company for details.
Fresenius Medical Care recalls Stay-Safe Luer Lock Adapter 4 in due to peroxide cross-linked tubing leaching NDL PCBAs. Affected units include model 050-95003 with specific UDI/DI numbers. Consumers should contact the manufacturer for details.
Fresenius recalls 6000mL peritoneal dialysis solution bags with potential lack of sterility. This affects patients using the product for kidney treatment. Contact Fresenius for details.
Fresenius Medical Care recalls Liberty Select cyclers with model numbers RTLR180343 and RTLR180111 due to potential incorrect time stamps on treatment reports sent to clinics. Affected units may require correction to ensure accurate patient data.
Fresenius Medical Care recalls Stay Safe Cap model 050-95012 due to labeling updates needed for safety warnings. All lots affected.
Fresenius Medical Care recalls 2008T HD SYS CDX BLUESTAR hemodialysis machines due to potential PCBA leaching from tubing. Affected units have specific serial numbers; contact for details.
Recall of Fresenius 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. Affected units have specific serial numbers. Consumers should check their device and contact Fresenius for guidance.
Recall of 2008T HD SYS CDX W/BIBAG BLUESTAR hemodialysis machines due to potential PCBA leaching from tubing. Affected units have specific serial numbers listed. No remedy provided in official notice.
Fresenius recalls 2008T GEN 2 Bibag hemodialysis machines with potential PCBA leaching from tubing. Affected units have specific serial numbers. Contact for details.
Fresenius Medical recalls 2008T Hemodialysis Systems with Bibag due to potential PCBA leaching from tubing. Affected units have specific serial numbers listed in the recall notice.
Recall of 2008T HD SYS hemodialysis machines with potential PCBA leaching from tubing. Affected units have specific serial numbers and model numbers. No remedy provided in official notice.
Recall of 2008T Hemodialysis SYS with CDX models due to potential PCBA leaching from tubing. Affected units have specific serial numbers; contact manufacturer for details.
Recall of 2008T HD SYS W/O CDX BLUESTAR hemodialysis machines due to potential PCBA leaching from tubing. Affected units have specific serial numbers. Contact manufacturer for details.
Fresenius Medical Care recalls 10ml syringes with potential blood backfill leakage and foreign material. Affected units include all lots of Part Number 15-R010-0.
Fresenius Medical Care recalls 10ML syringes with potential blood backfill leakage and foreign material. Affected units include all lots of Part Number 15-10ML-0.
Fresenius Medical Care recalls 3ML Syringe Luer Lock with 20GX1 needle (Part 15-03ML-0) due to potential blood backfill leakage and foreign material. All units are affected.
Fresenius Medical Care recalls 0.9% Sodium Chloride Injection (100mL) with potential sterility issues. Affected lots expired by June 2023. Consumers should contact for details.
Fresenius Medical Care recalls 0.9% Sodium Chloride Injection (100mL) with potential sterility issues. This saline solution may leak, causing contamination risks. Consumers should check lot numbers and contact the company for details.
Fresenius Medical Care recalls NaturaLyte Liquid Acid concentrate (part number 08-0231-4) due to incorrect potassium chloride labeling on labels. This affects dialysis patients using the product.
Fresenius Medical Care recalls 2008T and 2008TBluestar hemodialysis machines with CDX software versions 2.72 or earlier that may show false 'Remove USB 2 Device' alerts due to electromagnetic interference.
Fresenius recalls AquaC UNO H hemodialysis reverse osmosis units due to missing ferrite cores in internal cables, affecting electromagnetic compatibility. No remedy specified in official notice.
Fresenius recalls AquaC UNO H hemodialysis units with missing ferrite cores in ethemet cables, risking electromagnetic interference. Affected units have specific serial numbers and part numbers.
Fresenius Medical Care recalls AquaC UNO H devices with specific serial numbers due to potential electrical shock risk from misaligned internal ethernet cables. Affected units may cause harm to service technicians if the ethernet port is touched.
Fresenius recalls AquaC UNO H medical devices with potential electrical shock hazard if ethernet port is touched due to misaligned internal cable. Affected units have specific serial numbers and part numbers.
Fresenius Medical Care recalls NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal due to potential leaks from improper storage, which could cause biological contamination and bloodstream infections. Learn if you have the affected product.
Fresenius recalls Naturalyte Liquid Acid 2.0K 2.5Ca bottles with caps labeled 'Sealed for your Protection' that may not be safe for hemodialysis use. Affected units have specific lot numbers and expiration dates.
Fresenius Medical Care recalls NATURALYTE Liquid Acid 3.0K 3.0Ca for bottles with caps labeled 'Sealed for your Protection' that aren't qualified for use in hemodialysis. This affects patients with kidney failure needing dialysis.
Fresenius Medical Care recalls Optiflux 200NRe dialyzers with model 0500320E due to potential cold exposure during manufacturing. Affected units may have been distributed after exceeding safe temperature ranges.
Fresenius Medical Care recalls Novalung Sensor Box (F30000163) due to potential communication errors between flow sensor and sensor box, which may cause disabled flow measurement and air bubble detection during respiratory support.
