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Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc. Recalls

All product recalls associated with Fresenius Medical Care Holdings, Inc..

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Recall Summary

Total Recalls

54

Past Year

4

Class I (Serious)

0

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 54 recalls

5008X CAREsystem (Fresenius) – Software Anomaly Risk (2025)

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.

FDAOct 25, 2025LA, MA, MN• Fresenius Medical Care Holdings, Inc.

Optiflux Dialyzer (Fresenius) – Cap Configuration (2025)

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.

FDAAug 29, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

Sodium Chloride Injection (Fresenius) - Sterility Concern (2025)

Lack of Assurance of Sterility

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Moderate

FDAMay 27, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

5008X HDF Blood Tubing (Fresenius) – Potential Blood Leak (2025)

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.

FDAApr 29, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

Dialyzer Optiflux 160NRe (Fresenius) – Internal Blood Leak Risk (2024)

Potential for internal blood leaks due to cracked polyurethane

FDADec 5, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 1...

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.

FDAAug 8, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Delflex Peritoneal Dialysis Solution (Fresenius) – Tube Weld Failure (2024)

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Class IIModerate

FDAJun 18, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blo...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Ro...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Bloo...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pum...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood P...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pu...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Bloo...

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.

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: US AquaA 900H-Typ USA-3 x 208v-Intended for the purificat...

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.

FDAMay 16, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Blood Pump Rotor, Model Number: F40015481 Rev A

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.

FDAApr 17, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: 2008T BlueStar Hemodialysis Machine, Model 191124 with Co...

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.

FDAApr 17, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Novalung sensor box is a component of the Novalung Consol...

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.

FDAApr 8, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: stay-safe /Safe Lock Catheter Ext. 12 in

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.