FreshRecalls

Fresenius Medical Care Holdings recalls

5 recent recalls on record for Fresenius Medical Care Holdings in CPSC, NHTSA, and FDA data as of July 24, 2026 at 12:00 AM UTC.

Models with recalls

5008X Blood Tubing Set (1)Bicarby Dialysate (2)DELFLEX (2)

All Fresenius Medical Care Holdings recalls

FDA Class II · Medical device · July 15, 2026

5008X Blood Tubing Set recall — Fresenius Medical Care Holdings, Inc.

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

Official ID Z-2702-2026 · Official record ↗

FDA Class II · Medical device · June 17, 2026

Bicarby Dialysate recall — Fresenius Medical Care Holdings, Inc.

There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the pro…

Official ID Z-2401-2026 · Official record ↗

FDA Class II · Medical device · June 17, 2026

Bicarby" Dialysate recall — Fresenius Medical Care Holdings, Inc.

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-…

Official ID Z-2321-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Official ID D-0513-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Official ID D-0512-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked July 24, 2026 at 12:00 AM UTC.