Browse Device Recalls
146 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 146 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 146 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 28, 2021 | 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powd... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each int... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage s... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 g... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 18, 2021 | AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intende... | AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideli... | Class II | Fresenius Medical Care Holdings, Inc. |
| Dec 17, 2020 | Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concent... | Bottles Missing Product Label | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Us... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product U... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Us... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Sep 12, 2020 | Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR18... | The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked... | Class II | Fresenius Medical Care Holdings, Inc. |
| Sep 1, 2020 | AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodia... | Incorrectly crimped connectors were installed on the main protective earth conductor on these mac... | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 12, 2020 | Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 19... | A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 12, 2020 | Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T ... | A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jan 29, 2020 | Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used... | The firm is replacing pressure transducers with an improved design due to an increase in customer... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jul 16, 2015 | Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Conce... | Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. | Class II | Fresenius Medical Care Holdings, Inc. |
| May 20, 2015 | NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodial... | Bacterial contamination. | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 27, 2015 | CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real ... | Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber | Class II | Fresenius Medical Care Holdings, Inc. |
| Feb 20, 2015 | 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WIT... | The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... | Class II | Fresenius Medical Care Holdings, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.