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Fresenius Medical Care Renal Therapies Group, LLC FDA Recalls
9 recalls on file across devices, 0 of them Class I and 9 still open. Matched by name to FMS.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3Class IIAug 10, 2026Heightened probability of blood leak from the connection bet |
| 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8Class IIAug 10, 2026Heightened probability of blood leak from the connection bet |
| 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6Class IIAug 10, 2026Heightened probability of blood leak from the connection bet |
| 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3CClass IIAug 10, 2026Heightened probability of blood leak from the connection bet |
| CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;Class IIJul 29, 2026Communication to recommend reviewing the IFU and ensuring th |
| Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Class IIJul 14, 2026Complaints of blue-green discoloration in product |
| GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate HemodialyClass IIJul 14, 2026Complaints of blue-green discoloration in product |
| NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08Class IIJul 14, 2026Complaints of blue-green discoloration in product |
| Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.Class IIJun 30, 2026Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) h |