Fresenius Medical Care Holdings, Inc.

33 FDA enforcement actions

33 Total Recalls

0 Class I

26 Class II

7 Class III

Firm Details

Product Types: device, drug
States: MA

All Recalls

Class II: Risk 10/25/2025 device

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.
Class II: Risk 08/29/2025 device

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.
Class II: Risk 05/27/2025 drug

Lack of Assurance of Sterility
Class II: Risk 04/29/2025 device

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.
Class II: Risk 12/05/2024 device

Potential for internal blood leaks due to cracked polyurethane
Class II: Risk 08/08/2024 device

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.
Class II: Risk 06/18/2024 drug

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 06/03/2024 device

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.
Class II: Risk 05/16/2024 device

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.
Class II: Risk 04/17/2024 device

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.
Class II: Risk 04/17/2024 device

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.
Class II: Risk 04/17/2024 device

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.
Class II: Risk 04/17/2024 device

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.
Class II: Risk 04/17/2024 device

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.
Class II: Risk 12/28/2023 drug

Lack of Sterility Assurance
Class II: Risk 05/23/2023 drug

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Class II: Risk 11/22/2022 drug

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class II: Risk 10/11/2022 drug

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class II: Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.
Class III: Low Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.
Class III: Low Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.
Class III: Low Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.
Class III: Low Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.
Class III: Low Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.
Class III: Low Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.
Class III: Low Risk 04/28/2021 drug

Temperature Abuse: Product exposed to temperature outside specified limits.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.