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Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

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DateProductReasonClassFirm
Jul 31, 2012 V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usag... Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ve... Class I Respironics California Inc
Jul 31, 2012 cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecula... It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packag... Class III Roche Molecular Systems, Inc.
Jul 30, 2012 DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 throu... A condition can occur during renumbering of the patient database using the DEXCopy feature. When... Class II Imaging Sciences International, LLC
Jul 30, 2012 Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital... Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. ... Class II Siemens Healthcare Diagnostics, Inc.
Jul 27, 2012 The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... Class II Integra Limited
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLin... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... Class II Integra Limited
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner ... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured rep... Content entered into the "Conclusions" free text box on the Report Writer screen was not represen... Class II AGFA Corp.
Jul 27, 2012 Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate che... A drafting error during an unrelated design change has led to 4 misleading dimensions on the draw... Class II Biomet U.K., Ltd.
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scann... On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not function... Class II Quality Electrodynamics LLC
Jul 27, 2012 The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has t... Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result i... Class II Bio-Rad Laboratories
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hy... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS R... Offset Bushings associated with the lots identified were mismarked: the rotational reference numb... Class II Stryker Howmedica Osteonics Corp.
Jul 27, 2012 Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS ... Offset Bushings associated with the lots identified were mismarked: the rotational reference numb... Class II Stryker Howmedica Osteonics Corp.
Jul 27, 2012 Multileaf Collimator To be used for single or multiple fractions, delivere... Information released with the product Agility did not originally contain information on compatibi... Class II Elekta, Inc.
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 26, 2012 Serial interface module RS-485 Product Usage: The System 1 provides perfu... Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated ... St. Jude Medical has informed your doctor that a number of cases have been reported in which disc... Class II St. Jude Medical
Jul 26, 2012 Interface module for CDl System 100/101 Product Usage: The Interface Modu... Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model numbe... Philips determined that it is important to clarify information in the Owner's Manual and keep cus... Class II Philips Medical Systems North America Co. Phi...
Jul 26, 2012 Interface module for CDl System 500 Product Usage: The Interface Module f... Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical ... When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in t... Class II Stryker Orthobiologics, Inc.
Jul 26, 2012 System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall#... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 Serial interface module RS-232 Product Usage: The System 1 provides perfu... Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: E... St. Jude Medical has informed your doctor that a number of cases have been reported in which disc... Class II St. Jude Medical
Jul 26, 2012 Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured b... Philips determined that it is important to clarify information in the Owner's Manual and keep cus... Class II Philips Medical Systems North America Co. Phi...
Jul 26, 2012 System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall#... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the mana... As part of St. Jude Medical's routine tracking and product monitoring, they have received a total... Class II St. Jude Medical
Jul 25, 2012 Myocardial Heart Wires Intended for temporary atrial and ventricular pacin... Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C... Class II Oscor, Inc.
Jul 25, 2012 Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, S... There is a possibility that the screw channel that holds the rod in place may be out of tolerance... Class II Aesculap Implant Systems LLC
Jul 25, 2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... Essenta DR C-Arm may fall Class II Philips Healthcare Inc.
Jul 25, 2012 Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ... Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board th... Class II Siemens Healthcare Diagnostics, Inc
Jul 24, 2012 Access Folate Calibrators, Part Number: A14207. The Access Folate assay is... Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevate... Class II Beckman Coulter Inc.
Jul 24, 2012 Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended ... Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22,... Class II Capintec Inc
Jul 24, 2012 DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The de... A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potent... Class II DePuy Spine, Inc.
Jul 24, 2012 Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Cali... Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevate... Class II Beckman Coulter Inc.
Jul 24, 2012 Altrx" Altralinked" Polyethylene liners Description: An acetabular liner i... In the recalled lot, the products were not machined according to the production router, a size 52... Class II DePuy Orthopaedics, Inc.
Jul 23, 2012 VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek Sys... Review of instrument software databases and investigation of two customer reports determined that... Class III Trek Diagnostic Systems
Jul 23, 2012 Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.... Software anomaly may result in incorrect values and interpretations. The initial vital signs read... Class II Cisco Systems Inc
Jul 20, 2012 CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is ... GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. The... Class II GE Healthcare, LLC
Jul 20, 2012 Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil... Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators... Class II Galil Medical, Inc.
Jul 20, 2012 TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica... Product is missing the label on the internal packaging. Class III Teleflex Medical
Jul 19, 2012 Laserworld RGB & Piko Nano RGB Models All models are laser light show proj... A potential lack of certification, and/or missing laser certification, laser safety warning and a... Class II Laserworld Usa Inc
Jul 19, 2012 Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06... Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control ... Class III Abbott Point Of Care Inc.
Jul 18, 2012 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle ... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 syngo Imaging XS. Radiological image processing system. There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some s... Class II Siemens Medical Solutions USA, Inc
Jul 18, 2012 syngo.plaza, Model number 10592457. Intended use: radiological image proc... There is a potential malfunction in which a miscalculation occurs for images with pixel depth val... Class II Siemens Medical Solutions USA, 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.