Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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Date	Product	Reason	Class	Firm
Nov 21, 2013	Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile ...	Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ...	Class II	Ziehm Imaging Inc
Nov 21, 2013	Normative Data Template CD for use with the I-Portal devices. Used to meas...	The data provided on the Normative Data Template CD for use with the I-Portal devices has not rec...	Class II	Neuro Kinetics, Inc.
Nov 21, 2013	Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluorosc...	Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ...	Class II	Ziehm Imaging Inc
Nov 21, 2013	Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg ...	Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in sma...	Class II	Remel Inc
Nov 21, 2013	ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for ...	Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a rev...	Class II	Horiba Instruments, Inc dba Horiba Medical
Nov 21, 2013	Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mob...	Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ...	Class II	Ziehm Imaging Inc
Nov 21, 2013	SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS ...	Customers indicated fluctuations in environmental conditions sites and gradual degradation/deform...	Class II	Steris Corporation
Nov 21, 2013	3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular B...	Specific lots of Imprint II and Paradigm impression material refill packs are being recalled beca...	Class II	3M Company - Health Care Business
Nov 21, 2013	Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu...	Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ...	Class II	Ziehm Imaging Inc
Nov 20, 2013	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Univ...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to sec...	Mismarked and unmarked screws	Class II	SpineFrontier, Inc.
Nov 20, 2013	Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the In...	Mismarked and unmarked screws	Class II	SpineFrontier, Inc.
Nov 20, 2013	PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-801...	Screw inserters may not mate properly with hex interface of the screws.	Class II	SpineFrontier, Inc.
Nov 20, 2013	All brochures printed before November 20, 2013 for the HyperBlue 1530 medical...	Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had...	Class II	Hyperion Medical
Nov 20, 2013	ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses ...	Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac...	Class II	CooperVision Inc.
Nov 20, 2013	Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses,...	Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac...	Class II	CooperVision Inc.
Nov 20, 2013	GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery ...	GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection...	Class II	GE Healthcare, LLC
Nov 20, 2013	Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single u...	Stryker received reports from the field of the impaction plate dissociating/fracturing from the m...	Class II	Stryker Howmedica Osteonics Corp.
Nov 20, 2013	ORCHESTRA/ORCHESTRA PLUS Programmer	Sorin has voluntarily issued a notification to physicians related to the overestimation of the re...	Class II	Sorin Group Italia S.r.l.
Nov 20, 2013	PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-801...	Screw inserters may not mate properly with hex interface of the screws.	Class II	SpineFrontier, Inc.
Nov 20, 2013	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Unive...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univ...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to s...	Mismarked and unmarked screws	Class II	SpineFrontier, Inc.
Nov 20, 2013	Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to se...	Mismarked and unmarked screws	Class II	SpineFrontier, Inc.
Nov 20, 2013	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Unive...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Inte...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8...	Screw inserters may not mate properly with hex interface of the screws.	Class II	SpineFrontier, Inc.
Nov 20, 2013	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univ...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straig...	Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scis...	Class III	Edwards Lifesciences, LLC
Nov 19, 2013	Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock ...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-pa...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, Inc.
Nov 19, 2013	Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,sing...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, Inc.
Nov 19, 2013	NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green...	This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins...	Class II	Zimmer, Inc.
Nov 19, 2013	Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Dr...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex...	Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the de...	Class III	Ultradent Products, Inc.
Nov 19, 2013	NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thic...	This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins...	Class II	Zimmer, Inc.
Nov 19, 2013	Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Syst...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, Inc.
Nov 19, 2013	NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm He...	This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins...	Class II	Zimmer, Inc.
Nov 19, 2013	NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm He...	This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins...	Class II	Zimmer, Inc.
Nov 19, 2013	Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Syst...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Dra...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thic...	This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins...	Class II	Zimmer, Inc.
Nov 19, 2013	Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery Syst...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-pack...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, Inc.
Nov 19, 2013	Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Sys...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-pac...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, Inc.
Nov 19, 2013	Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-pac...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, Inc.
Nov 19, 2013	Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery Syst...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-p...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, 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.