Fresenius Medical Care Holdings, Inc.: 85 recalls on record

Recalls filed with 1 agency: FDA (85).

First recall on record: July 4, 2012. Most recent: July 15, 2026.

Risk classification: Class I: 8 · Class II: 63 · Class III: 14

Most recent recalls

DateAgencyProduct
July 15, 2026FDA5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descripti…Z-2702-2026
June 17, 2026FDABicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G…Z-2321-2026
June 17, 2026FDABicarby Dialysate; Model number: RFP-400-G;Z-2401-2026
May 13, 2026FDADELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for I…D-0513-2026
May 13, 2026FDADELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for I…D-0512-2026
July 2, 2025FDA0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medica…D-0490-2025
September 18, 2024FDABlood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware v…Z-3124-2024
July 24, 2024FDADELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and …D-0608-2024
July 17, 2024FDARTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model N…Z-2344-2024
July 17, 2024FDA190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Numb…Z-2343-2024
July 17, 2024FDARTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model …Z-2347-2024
July 17, 2024FDA190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Numbe…Z-2340-2024
July 17, 2024FDARTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model N…Z-2346-2024
July 17, 2024FDA190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F4001…Z-2341-2024
July 17, 2024FDA191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number…Z-2342-2024
July 17, 2024FDARTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F4…Z-2345-2024
June 19, 2024FDAUS AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemo…Z-2141-2024
May 29, 2024FDA2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model…Z-1870-2024
May 29, 2024FDABlood Pump Rotor, Model Number: F40015481 Rev AZ-1866-2024
May 29, 2024FDA2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model…Z-1867-2024
May 29, 2024FDA2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model…Z-1869-2024
May 29, 2024FDA2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model…Z-1868-2024
May 22, 2024FDANovalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long…Z-1822-2024
April 3, 2024FDAstay-safe /Luer Lock Catheter Ext. 18 inZ-1326-2024
April 3, 2024FDAstay-safe /Luer Catheter Ext. 6 inZ-1327-2024

Questions about this company

How many recalls does Fresenius Medical Care Holdings, Inc. have?
Recalert has 85 U.S. recalls on record for Fresenius Medical Care Holdings, Inc., published between July 4, 2012 and July 15, 2026.
What was the most recent Fresenius Medical Care Holdings, Inc. recall?
FDA recall Z-2702-2026, published July 15, 2026: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard …
Which agencies have handled Fresenius Medical Care Holdings, Inc. recalls?
Fresenius Medical Care Holdings, Inc. appears as the recalling firm in recalls from: FDA (85).

Do you carry products from Fresenius Medical Care Holdings, Inc.? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Related companies