Recall archive
61 recalls · page 2 of 3
Reported Sep 28, 2022
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2022
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2022
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological…
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating…
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between…
FDA (openFDA device enforcement)
Reported Jul 28, 2021
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — Exposed to freezing temperatures due to refrigerated truck malfunctions
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Temperature Abuse: Product exposed to temperature outside specified limits.
7 more products in this recall
FDA (openFDA drug enforcement)
Reported May 19, 2021
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring…
FDA (openFDA device enforcement)
Reported Feb 10, 2021
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Bottles Missing Product Label
FDA (openFDA device enforcement)
Reported Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
29 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 18, 2020
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the…
FDA (openFDA device enforcement)
Reported Oct 21, 2020
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is…
FDA (openFDA device enforcement)
Reported Apr 29, 2020
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 1, 2020
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of…
FDA (openFDA device enforcement)
Reported Mar 25, 2020
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: 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 — CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
FDA (openFDA drug enforcement)
Reported Aug 19, 2015
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
FDA (openFDA device enforcement)
Reported Jul 1, 2015
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Bacterial contamination.
FDA (openFDA device enforcement)
Reported Jun 17, 2015
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
FDA (openFDA device enforcement)
Reported May 6, 2015
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product details — The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2015
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
FDA (openFDA device enforcement)
Reported Feb 4, 2015
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Unqualified power assemblies shipped to customers.
FDA (openFDA device enforcement)
Reported Oct 1, 2014
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Product was held at temperature above the labeled recommended storage temperature
FDA (openFDA device enforcement)
Reported Sep 24, 2014
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Products were held at improper storage temperature
5 more products in this recall
FDA (openFDA device enforcement)
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