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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.

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DateProductReasonClassFirm
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008T with the following product code and ... 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.
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008K2 with the following product code and... 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.
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008K with the following product code and ... 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.
Dec 19, 2014 Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL100... Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope Class II Fresenius Medical Care Holdings, Inc.
Dec 16, 2014 ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following mach... Unqualified power assemblies shipped to customers. Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000... Product was held at temperature above the labeled recommended storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 ... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 3... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 P... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC ... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
May 1, 2014 NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with ... Container cap may contain foreign material- 0.60% - 0.80% Manganese Class III Fresenius Medical Care Holdings, Inc.
Apr 25, 2014 Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and... 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disco... Class II Fresenius Medical Care Holdings, Inc.
Apr 25, 2014 Revision K Actuator Test Boards sold as replacement parts for use with Frese... 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disco... Class II Fresenius Medical Care Holdings, Inc.
Apr 10, 2014 Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-... Naturalyte Liquid Bicarbonate maybe contaminated Class I Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use a... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute o... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Dec 17, 2013 Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Pa... Bicarbonate Jug Adapter distributed prior to 510(k) approval Class II Fresenius Medical Care Holdings, Inc.
Nov 12, 2013 Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2... 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirc... Class II Fresenius Medical Care Holdings, Inc.
Oct 14, 2013 Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Lib... Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result ... Class II Fresenius Medical Care Holdings, Inc.
Aug 29, 2013 Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9.... Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... Class II Fresenius Medical Care Holdings, Inc.
Aug 29, 2013 Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended... Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... Class II Fresenius Medical Care Holdings, Inc.
Aug 29, 2013 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catal... Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... Class II Fresenius Medical Care Holdings, Inc.
Jun 3, 2013 Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 ... Cassette may leak during set up or during peritoneal dialysis treatment Class II Fresenius Medical Care Holdings, Inc.
May 24, 2013 Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub... Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Pro... Class II Fresenius Medical Care Holdings, Inc.
Apr 1, 2013 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an o... Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, ... Class II Fresenius Medical Care Holdings, Inc. dba Renal...
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Oct 12, 2012 Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. ... There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate ... Class II Fresenius Medical Care Holdings, Inc.
Mar 29, 2012 Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-... Risk of Alkalosis with acetate containing dialysis acid concentrates Class I Fresenius Medical Care Holdings, Inc.
Mar 29, 2012 Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD... Risk of Alkalosis with acetate containing dialysis acid concentrates Class I 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.