Fresenius Medical Care Holdings, Inc.
163 recalls on record · Latest: May 13, 2026
Fresenius Medical Care Holdings, Inc. Recall Insight
Fresenius Medical Care Holdings, Inc. appears on 163 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.160% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 13, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 50 entries, severity tagging shows 16 critical, 33 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 2 distinct product categories, with issuing agencies dominated by FDA Devices (42), FDA Drug (8). The date window on this page runs from Sep 28, 2022 to May 13, 2026.
Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part …
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part…
5008X CAREsystem +CLiC +CDX;
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM,…
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC…
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b.…
Dialyzer Optiflux 160NRe
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines w…
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL exce…
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Nu…
Blood Pump Rotor, Model Number: F40015481 Rev A
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that …
stay-safe /Luer Lock Adapter 4 in
stay-safe /Luer Lock Catheter Ext. 18 in
stay-safe /Luer Catheter Ext. 6 in
stay-safe /Luer Lock Catheter Ext. 12 in
stay-safe /Safe Lock Catheter Ext. 12 in
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 0245…
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Stay Safe Cap
2008T HD SYS. W/O CDX BLUESTAR
2008T Hemodialysis SYS, with CDX
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
2008T Hemodialysis System w/Bibag
2008T GEN 2 Bibag without CDX
2008T HD SYS. CDX W/BIBAG BLUESTAR
2008T Hemodialysis System without CDX
2008T HD SYS. CDX BLUESTAR
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-…
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 19071…
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, …
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, …
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1…
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 V…
Nearby Manufacturers
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Compare Fresenius Medical Care Holdings, Inc. with Zimmer Biomet, Inc. →
Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.