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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

Class I (Serious)

Most Recent

Nov 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 761–780 of 2399 recalls

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

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Class III

Low

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFELX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Sodium Chloride 0.9% (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIModerate

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Temperature Abuse (2021)

Temperature Abuse: Product exposed to temperature outside specified limits.

Class IIILow

FDAApr 28, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: The Fresenius APD Luer-Lock Adapter, Catalog number 050-9...

Exposed to freezing temperatures due to refrigerated truck malfunctions

FDAApr 28, 2021TX• Fresenius Medical Care Holdings, Inc.

Roche Diagnostics Operations, Inc.: IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETT...

Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

FDAApr 26, 2021Nationwide• Roche Diagnostics Operations, Inc.

Dutch Ophthalmic USA, Inc.: Illuminated Stepped Laser Probe Curved-for use in combina...

Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

FDAApr 14, 2021Nationwide• Dutch Ophthalmic USA, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Pr...

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160...

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Merits Holdings Co. dba Merits Health Products, Inc.: Power Wheelchair

Seat baseplate pin has broken in the field.

FDAApr 1, 2021Nationwide• Merits Holdings Co. dba Merits Health Products, Inc.

Merits Holdings Co. dba Merits Health Products, Inc.: Scooter

Seat baseplate pin has broken in the field.

FDAApr 1, 2021Nationwide• Merits Holdings Co. dba Merits Health Products, Inc.

Itraconazole Capsules (Jubilant Cadista) - Failed Dissolution (2021)

Failed Dissolution Specifications

Class IIModerate

FDAApr 1, 2021Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Tuscan Garden Ranch Dressing (Richelieu Foods) – Incorrect Label (2021)

An incorrect label was applied to the back of ranch dressing bottles. The incorrect label contained the ingredient information for zesty Italian dressing which fails to disclose the presence of milk and egg present in the product.

Class IIModerate

FDAMar 29, 2021AR, IL, IN +12 more• Richelieu Foods, Inc.

Roche Molecular Systems, Inc.: cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagen...

Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

FDAMar 25, 2021Nationwide• Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc.: cobas Liat Analyzer: respiratory virus panel nucleic acid...

FDAMar 25, 2021Nationwide• Roche Molecular Systems, Inc.

Mometasone Furoate Topical Solution (Cosette) – CGMP Deviations (2021)

CGMP Deviaitons

Class IIModerate

FDAMar 25, 2021Nationwide• Cosette Pharmaceuticals, Inc.