Recall archive
61 recalls · page 1 of 3
Reported Jul 15, 2026
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Reason for recall — Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the…
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility: Potential leaks from perforations in bags.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 24, 2025
5008X CAREsystem +CLiC +CDX;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if…
FDA (openFDA device enforcement)
Reported Oct 15, 2025
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Reason for recall — To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a…
FDA (openFDA device enforcement)
Reported Jul 2, 2025
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility
FDA (openFDA drug enforcement)
Reported Jun 25, 2025
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD),…
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Dialyzer Optiflux 160NRe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Potential for internal blood leaks due to cracked polyurethane
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure…
FDA (openFDA device enforcement)
Reported Jul 24, 2024
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
FDA (openFDA drug enforcement)
Reported Jul 17, 2024
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104,…
FDA (openFDA device enforcement)
Reported May 29, 2024
Blood Pump Rotor, Model Number: F40015481 Rev A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting…
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206…
FDA (openFDA device enforcement)
Reported Apr 3, 2024
stay-safe /Safe Lock Catheter Ext. 12 in
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Medical Care Holdings, Inc.
Matched: Brand — The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Lack of Sterility Assurance
FDA (openFDA drug enforcement)
Reported Jan 3, 2024
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Stay Safe Cap
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Updating the labeling to include additional warnings and contraindications for potential side effects.
FDA (openFDA device enforcement)
Reported Oct 18, 2023
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Medical Care Holdings, Inc.
Matched: Brand — There is a potential for blood backfill leakage and foreign material.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
FDA (openFDA drug enforcement)
Reported Dec 28, 2022
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive…
FDA (openFDA device enforcement)
Reported Dec 14, 2022
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
FDA (openFDA drug enforcement)
Reported Nov 16, 2022
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl…
FDA (openFDA device enforcement)
Reported Oct 26, 2022
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
FDA (openFDA drug enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up