FDA recall record · openFDA
Fresenius Medical Care Holdings, Inc.
46 FDA recalls on record (2023–2026) — 6 drug,40 device. 45 still ongoing.
16
Class I (most serious)
29
Class II
1
Class III
45
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by 13
Potential PCBA leaching from tubing of hemodialysis machines. 8
The peroxide cross-linked tubing has leachables identified as NDL PCBAs. 5
There is a potential for blood backfill leakage and foreign material. 3
Lack of Assurance of Sterility: Potential leaks from perforations in bags. 2
Recalls
stay-safe /Luer Lock Adapter 4 in Class I 2024-01-23 stay-safe /Luer Lock Catheter Ext. 18 in Class I 2024-01-23 stay-safe /Luer Catheter Ext. 6 in Class I 2024-01-23 stay-safe /Luer Lock Catheter Ext. 12 in Class I 2024-01-23 stay-safe /Safe Lock Catheter Ext. 12 in Class I 2024-01-23 2008T HD SYS. W/O CDX BLUESTAR Class I 2023-09-06 2008T Hemodialysis SYS, with CDX Class I 2023-09-06 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case Class I 2023-08-08 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case Class I 2023-08-08 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR Class I 2023-09-06 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case Class I 2023-08-08 2008T Hemodialysis System w/Bibag Class I 2023-09-06 2008T GEN 2 Bibag without CDX Class I 2023-09-06 2008T HD SYS. CDX W/BIBAG BLUESTAR Class I 2023-09-06 2008T Hemodialysis System without CDX Class I 2023-09-06 2008T HD SYS. CDX BLUESTAR Class I 2023-09-06 DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2 Class II 2026-04-06 DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, Class II 2026-04-06 Bicarby Dialysate; Model number: RFP-400-G; Class II 2026-05-07 Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; Class II 2026-05-12 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, Class II 2025-05-27 5008X CAREsystem +CLiC +CDX; Class II 2025-10-25 Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFL Class II 2025-08-29 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Class II 2025-04-29 DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Se Class II 2024-06-18 Blood Pump Rotor, Model Number: F40015481 Rev A Class II 2024-04-17 Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ Class II 2024-04-08 RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Class II 2024-04-17 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Class II 2024-04-17 RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. Class II 2024-04-17 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A Class II 2024-04-17 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 S Class II 2024-08-08 US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: Class II 2024-05-16 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A Class II 2024-06-03 Dialyzer Optiflux 160NRe Class II 2024-12-05 DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Med Class II 2023-12-28 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Wa Class II 2023-05-23 Stay Safe Cap Class II 2023-10-10 Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 Class III 2023-10-24
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.