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Fresenius Medical Care Holdings, Inc.

FDA Regulatory Profile

Summary

Total Recalls
161 (19 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-0936-2026Class II5008X CAREsystem +CLiC +CDX;October 25, 2025
Z-0041-2026Class IIOptiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM,August 29, 2025
D-0490-2025Class II0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care NortMay 27, 2025
Z-1992-2025Class II5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X StaApril 29, 2025
Z-0801-2025Class IIDialyzer Optiflux 160NReDecember 5, 2024
Z-3124-2024Class IIBlood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005August 8, 2024
D-0608-2024Class IIDELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stJune 18, 2024
Z-2340-2024Class II190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F4001548June 3, 2024
Z-2343-2024Class II190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F400154June 3, 2024
Z-2341-2024Class II190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev AJune 3, 2024
Z-2347-2024Class IIRTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40June 3, 2024
Z-2345-2024Class IIRTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 RevJune 3, 2024
Z-2342-2024Class II191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481June 3, 2024
Z-2346-2024Class IIRTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F400June 3, 2024
Z-2344-2024Class IIRTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F400June 3, 2024
Z-2141-2024Class IIUS AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis VMay 16, 2024
Z-1869-2024Class II2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F4April 17, 2024
Z-1867-2024Class II2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F4April 17, 2024
Z-1866-2024Class IIBlood Pump Rotor, Model Number: F40015481 Rev AApril 17, 2024
Z-1868-2024Class II2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F4April 17, 2024