Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 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 774 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 14, 2014	GE Healthcare Optima CT580/Discovery CT590RT scanners running software versio...	GE Healthcare has recently become aware of a potential safety issue due to a software issue assoc...	Class II	GE Healthcare, LLC
Feb 7, 2014	HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis...	In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional inform...	Class II	Leica Biosystems Imaging, Inc.
Feb 7, 2014	MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: ...	Tyvek packaging may be worn, causing loss of package integrity.	Class II	Biocardia, Inc.
Jan 21, 2014	Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091...	Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.	Class II	Dako North America Inc.
Dec 20, 2013	Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utiliz...	Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on S...	Class II	Zeiss, Carl Inc
Dec 6, 2013	Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml...	Reports that the product is not performing as expected. In house testing showed no staining on br...	Class II	Lab Vision Corporation
Nov 26, 2013	outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin...	Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906...	Class II	Biomet, Inc.
Nov 26, 2013	BD Interlink threaded lock cannula This is a locking blunt plastic cannula s...	BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the pote...	Class II	Becton Dickinson & Company
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
Oct 14, 2013	Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a...	Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ...	Class II	Philips Healthcare Informatics, Inc.
Oct 11, 2013	US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path ...	St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti...	Class II	St. Jude Medical
Oct 10, 2013	The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed ...	Nanosphere has received several reports relating to an increased rate of Processing Errors during...	Class II	Nanosphere, Inc.
Oct 10, 2013	The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali...	Nanosphere has received several reports relating to an increased rate of Processing Errors during...	Class II	Nanosphere, Inc.
Oct 3, 2013	Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Ti...	A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical B...	Class II	Synthes USA HQ, Inc.
Oct 1, 2013	Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated ...	There is an issue associated with Digital Pathology System (DPS) Software, in which the annotatio...	Class II	Omnyx Llc
Sep 30, 2013	Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr...	Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ...	Class II	Medtronic Neuromodulation
Sep 11, 2013	PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.	Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect sp...	Class II	SpineFrontier, Inc.
Sep 10, 2013	Dual Luer Lock Cap The device is intended for use as a cap for male or fem...	The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging...	Class II	Baxter Healthcare Corp.
Aug 26, 2013	Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating...	Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi...	Class II	Edwards Lifesciences, LLC
Aug 26, 2013	Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, ...	Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi...	Class II	Edwards Lifesciences, LLC
Aug 19, 2013	Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. ...	Lumenis has initiated a recall on certain models of Vision One System due to a potential for unin...	Class II	Lumenis, Inc.
Jul 31, 2013	Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumb...	Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction I...	Class II	Synthes USA HQ, Inc.
Jul 31, 2013	Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leic...	The affected lots of the product may contain a contaminant of fungus that can cause a loss of sta...	Class II	Leica Biosystems Newcastle Ltd.
Jun 12, 2013	Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ...	Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Jun 5, 2013	Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab...	The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presen...	Class II	Fisher Scientific Co
May 24, 2013	AMICUS Exchange Kit; Product Usage: This kit is designed for use with th...	Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339...	Class II	Fenwal Inc
May 10, 2013	Responder 5 is a nurse call communication system that connects patients with ...	A counterfeited electronic component was identified in the products affected. The component, a da...	Class II	Rauland-Borg Corp
May 8, 2013	8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distri...	Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors ver...	Class II	Intuitive Surgical, Inc.
May 3, 2013	-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples ...	The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ...	Class II	Surgical Instrument Service And Savings, Inc.
May 3, 2013	- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green...	The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ...	Class II	Surgical Instrument Service And Savings, Inc.
May 1, 2013	DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear ...	It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems	Class II	Elekta, Inc.
Apr 19, 2013	Centricity Enterprise Archive is a software product for receiving, archiving ...	GE Healthcare has become aware of a potential data loss issue associated with empty path names re...	Class II	Ge Healthcare It
Apr 17, 2013	CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 ...	During injection of cement, the water in the hydraulic pump leaks past the piston within the pump...	Class II	DePuy Spine, Inc.
Apr 17, 2013	CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CON...	During injection of cement, the water in the hydraulic pump leaks past the piston within the pump...	Class II	DePuy Spine, Inc.
Apr 17, 2013	CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFI...	During injection of cement, the water in the hydraulic pump leaks past the piston within the pump...	Class II	DePuy Spine, Inc.
Apr 12, 2013	LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk n...	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ...	Class II	Ethicon Endo-Surgery Inc
Apr 12, 2013	LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Tra...	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ...	Class II	Ethicon Endo-Surgery Inc
Apr 12, 2013	LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Pro...	Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ...	Class II	Ethicon Endo-Surgery Inc
Apr 9, 2013	HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is...	Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8...	Class II	Instrumentation Laboratory Co.
Apr 8, 2013	Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi...	The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th...	Class II	Ethicon Endo-Surgery Inc
Mar 14, 2013	Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: T...	Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly seale...	Class II	Edwards Lifesciences, LLC
Mar 12, 2013	The Centricity Laboratory System is intended to be an information system desi...	GE Healthcare has become aware of a potential safety issue associated with the use of GE Centrici...	Class II	GE Healthcare It
Mar 12, 2013	The Centricity Laboratory System is intended to be an information system desi...	GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instr...	Class II	GE Healthcare It
Feb 6, 2013	Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3...	The product has a Lithium Heparin contaminant which could adversely affect coagulation results po...	Class II	Heritage Labs International LLC
Feb 4, 2013	Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini...	Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein O...	Class II	Hospira Inc.
Feb 4, 2013	Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini...	Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and...	Class II	Hospira Inc.
Feb 4, 2013	Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini...	Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein O...	Class II	Hospira Inc.
Feb 4, 2013	Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini...	Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and...	Class II	Hospira Inc.
Jan 23, 2013	MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide;...	Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip...	Class II	Bard Peripheral Vascular Inc
Jan 15, 2013	DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. D...	Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck	Class II	DePuy Spine, 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.