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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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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DateProductReasonClassFirm
Mar 22, 2013 EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to auto... Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufa... Class II Advanced Sterilization Products
Mar 22, 2013 LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse ... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid ... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povi... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Numb... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, ... Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap m... Class II Medtronic MiniMed
Mar 22, 2013 ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. Fi... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 20... The recall was initiated because Advanced Sterilization Products (ASP) has determined that the ST... Class II Advanced Sterilization Products
Mar 21, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica... Class II Hospira Inc.
Mar 21, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica... Class II Hospira Inc.
Mar 21, 2013 Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanner... If the operator selects a patient name from the worklist using the mouse and then selects a diffe... Class II Philips Medical Systems (Cleveland) Inc
Mar 20, 2013 AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Che... Beckman Coulter, Inc. initiated this recall because there is a software error that has the potent... Class II Beckman Coulter Inc.
Mar 20, 2013 HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400IS... HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there a... Class II Horiba Instruments, Inc dba Horiba Medical
Mar 20, 2013 REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found i... Investigation of complaints found excessive use of the instrument could result in cracking on the... Class II Biomet U.K., Ltd.
Mar 19, 2013 GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (p... Some patients are obtaining access to the dosage reset codes required to change the settings on G... Class II Hospira Inc.
Mar 19, 2013 GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (p... Some patients are obtaining access to the dosage reset codes required to change the settings on G... Class II Hospira Inc.
Mar 19, 2013 Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Med... A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt ... Class II Accuray Incorporated
Mar 18, 2013 Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores a... The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code ... Class II Linvatec Corp. dba ConMed Linvatec
Mar 18, 2013 TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02... Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The b... Class II Loma Vista Medical
Mar 18, 2013 GemStar Pump - Battery Product Usage: The GemStar Pump is a small and li... Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview th... Class I Hospira Inc.
Mar 18, 2013 ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument f... Due to lack of sterilization. Class II Clorox Healthcare Holdings, LLC (dba HealthLink)
Mar 18, 2013 Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intend... If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended volt... Class II Integra Burlington MA, Inc.
Mar 18, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... Pump shutting off during use without warning. Class I Hospira Inc.
Mar 18, 2013 HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy. Due to lack of sterilization. Class II Clorox Healthcare Holdings, LLC (dba HealthLink)
Mar 18, 2013 PSS Select medical products***Biopsy Punches*** Disposable manual instrume... Due to lack of sterilization. Class II Clorox Healthcare Holdings, LLC (dba HealthLink)
Mar 18, 2013 LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, Inc.
Mar 18, 2013 Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray... The recall was initiated because Shimadzu Corporation has identified a potential issue in certain... Class II Shimadzu Medical Systems
Mar 18, 2013 NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a cas... Product may be mislabeled. Class II NxStage Medical, Inc.
Mar 18, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... Pump shutting off during use without warning. Class I Hospira Inc.
Mar 18, 2013 GemStar Pump - Battery Product Usage: The GemStar Pump is a small and ... Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview th... Class I Hospira Inc.
Mar 18, 2013 Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, Inc.
Mar 15, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... Class I Hospira Inc.
Mar 15, 2013 IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Repor... Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheter... Class II AGFA Corp.
Mar 15, 2013 Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pi... Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophth... Class II Insight Instruments, Inc.
Mar 15, 2013 The GemStar Pump is a small and lightweight, single channel infusion device d... The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... Class I Hospira Inc.
Mar 15, 2013 ACIST Medical Systems Inc. The ACIST Angiographic Injection System is inte... ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Auto... Class II Acist Medical Systems
Mar 15, 2013 McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care syst... There was an occurrence where the patient case data did not match the patient data when the case ... Class I MCKESSON TECHNOLOGIES INC.
Mar 15, 2013 IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model I... Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... Class II Intuitive Surgical, Inc.
Mar 15, 2013 IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da ... Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... Class II Intuitive Surgical, Inc.
Mar 15, 2013 Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea ver... Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Car... Class II Vital Images, Inc.
Mar 15, 2013 Vitrea¿ CT Brain Perfusion made available in various configurations under the... Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing... Class II Vital Images, Inc.
Mar 15, 2013 IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitat... Software design error in IMPAX CV 7.8 SU3 Class II AGFA Corp.
Mar 14, 2013 Precise Treatment Table. To be used as part of radiation therapy treatment... The Column rotation can accidentally be moved to a different position which in the locked position. Class II Elekta, Inc.
Mar 14, 2013 VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For t... Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outlie... Class II Ortho-Clinical Diagnostics
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

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.