Fresenius Medical Care Holdings, Inc. recalls

8 recalls on record · latest: April 6, 2026

Official U.S. recall history for Fresenius Medical Care Holdings, Inc., compiled from official government records.

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DELFLEX recalled over sterility concerns

April 6, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: Potential leaks from perforations in bags.

DELFLEX recalled over sterility concerns

April 6, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;

October 25, 2025 · Medical device recalls Moderate risk Several software anomalies with the potential to impact patient treatment, of w…

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…

August 29, 2025 · Medical device recalls Moderate risk To provide further information to the user to ensure proper use of the medical…

Fresenius Medical Care Holdings product recalled over sterility concerns

May 27, 2025 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

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,…

April 29, 2025 · Medical device recalls Moderate risk Potential of blood leak occurring between the lower port of the venous chamber…

Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe

December 5, 2024 · Medical device recalls Moderate risk Potential for internal blood leaks due to cracked polyurethane

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…

August 8, 2024 · Medical device recalls Moderate risk Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2…