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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

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

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 2461–2480 of 21320 recalls

Blood Pump Rotor (Fresenius) – component dislodgement (2024)

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.

Moderate

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

2008T BlueStar Hemodialysis Machine (Fresenius) – pump rotor issue (2024)

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.

Moderate

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

Diltiazem Hydrochloride (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class II

1...122 123124125 126...1066

Page 124 of 1066Next

Moderate

FDAApr 17, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

COBALT XT VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

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Fresenius Medical Care Holdings, Inc. Recalls

Recall Summary

Blood Pump Rotor (Fresenius) – component dislodgement (2024)

2008T BlueStar Hemodialysis Machine (Fresenius) – pump rotor issue (2024)

Diltiazem Hydrochloride (Glenmark) – Dissolution Failure (2024)

COBALT XT VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

PRIMO MRI VR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

MIRRO MRI VR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

CROME HF QUAD CRT-D Defibrillator (Medtronic) – manufacturing defect (2024)

PRIMO MRI DR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

EVERA MRI S VR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Medtronic Implantable Defibrillator (Medtronic) – manufacturing defect (2024)

RefleXion X1 Radiotherapy System (Reflexion) – dose error risk (2024)

EVERA S VR Defibrillator (Medtronic) – manufacturing defect (2024)

MIRRO MRI DR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

EVERA MRI S DR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

COBALT HF QUAD CRT-D Defibrillator (Medtronic) – manufacturing defect (2024)

CROME VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

COBALT XT HF QUAD CRT-D Defibrillator (Medtronic) – manufacturing defect (2024)

COBALT DR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Cobalt XT HF CDT-D Defibrillator (Medtronic) – manufacturing defect (2024)

COBALT VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)