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Fresenius Medical Care Holdings Recalls
166 recalls on record · July 4, 2012 to July 15, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
July 15, 2026Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush
Hazard: Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
June 17, 2026Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate; Model number: RFP-400-G;
Hazard: There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
June 17, 2026Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Hazard: Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
May 13, 2026DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2
Hazard: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
May 13, 2026DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,
Hazard: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
December 24, 2025Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;
Hazard: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
October 15, 2025Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFL
Hazard: To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
July 2, 2025DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,
Hazard: Lack of Assurance of Sterility
June 25, 2025Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,
Hazard: Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
January 15, 2025Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe
Hazard: Potential for internal blood leaks due to cracked polyurethane
September 18, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 S
Hazard: Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
July 24, 2024DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Se
Hazard: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
June 19, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:
Hazard: Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Blood Pump Rotor, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 22, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/
Hazard: Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
April 3, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Catheter Ext. 6 in
Hazard: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
April 3, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Lock Catheter Ext. 18 in
Hazard: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
April 3, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Lock Catheter Ext. 12 in
Hazard: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.