Fresenius Medical Care Holdings recalls
Fresenius Medical Care Holdings appears in 167 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- 5008X Blood Tubing Set, 24 units per case
FDA Device · Class II · 2026-07-15 · Fresenius Medical Care Holdings - Bicarby" Dialysate
FDA Device · Class II · 2026-06-17 · Fresenius Medical Care Holdings - Bicarby Dialysate
FDA Device · Class II · 2026-06-17 · Fresenius Medical Care Holdings - DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L…
FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings - DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L…
FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings - 5008X CAREsystem +CLiC +CDX
FDA Device · Class II · 2025-12-24 · Fresenius Medical Care Holdings - Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7…
FDA Device · Class II · 2025-10-15 · Fresenius Medical Care Holdings - 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323…
FDA Drug · Class II · 2025-07-02 · Fresenius Medical Care Holdings - 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-51…
FDA Device · Class II · 2025-06-25 · Fresenius Medical Care Holdings - Dialyzer Optiflux 160NRe
FDA Device · Class II · 2025-01-15 · Fresenius Medical Care Holdings - Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis…
FDA Device · Class II · 2024-09-18 · Fresenius Medical Care Holdings - DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx.…
FDA Drug · Class II · 2024-07-24 · Fresenius Medical Care Holdings - RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius…
FDA Device · Class II · 2024-06-19 · Fresenius Medical Care Holdings - 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary sup…
FDA Device · Class II · 2024-05-22 · Fresenius Medical Care Holdings - stay-safe /Luer Lock Catheter Ext. 12 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - stay-safe /Luer Lock Catheter Ext. 18 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - stay-safe /Luer Catheter Ext. 6 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - stay-safe /Safe Lock Catheter Ext. 12 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - stay-safe /Luer Lock Adapter 4 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltha…
FDA Drug · Class II · 2024-01-10 · Fresenius Medical Care Holdings - Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
FDA Device · Class III · 2024-01-03 · Fresenius Medical Care Holdings - Stay Safe Cap
FDA Device · Class II · 2023-12-13 · Fresenius Medical Care Holdings - 2008T GEN 2 Bibag without CDX
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 2008T HD SYS. CDX BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 2008T Hemodialysis SYS, with CDX
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 2008T HD SYS. W/O CDX BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 2008T Hemodialysis System without CDX
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 2008T Hemodialysis System w/Bibag
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, ND…
FDA Drug · Class II · 2023-06-07 · Fresenius Medical Care Holdings - 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1…
FDA Device · Class II · 2022-12-28 · Fresenius Medical Care Holdings - 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK,…
FDA Drug · Class II · 2022-12-14 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case
FDA Device · Class II · 2022-11-16 · Fresenius Medical Care Holdings