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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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.

Clear
DateProductReasonClassFirm
Jun 1, 2012 T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide ... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the ... Class II Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012 Sysmex XE-2100C Automated Hematology System; an automated differential cell c... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
May 31, 2012 Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right ... USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong pa... Class II Synthes (USA) Products LLC
May 31, 2012 Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is l... Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due ... Class II Biomet 3i, LLC
May 30, 2012 ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (... The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Ab... Class II Abbott Laboratories
May 30, 2012 Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 f... A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock... Class II SALTER LABS
May 29, 2012 Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Contr... Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram neg... Class II Microbiologics Inc
May 29, 2012 This voluntary medical device correction is related to Alcon products that pr... This medical device correction is related to Alcon products that present a 23G non-valved trocar ... Class II Alcon Research, LTD.
May 29, 2012 TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102... On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Tr... Class II Alphatec Spine, Inc.
May 29, 2012 MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. ... Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and e... Class II Sekisui Diagnostics Llc
May 29, 2012 Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is... There is a potential to save reports in RadReport with an Incorrect Final Status. Class II Mckesson Medical Imaging Group
May 29, 2012 syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. ... When using the syngo Quality Control package the system may not perform as intended for Multi-Rul... Class II Siemens Healthcare Diagnostics, Inc.
May 29, 2012 Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code... The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as run... Class III Clark Laboratories, Inc. (dba,Trinity Biotech USA)
May 29, 2012 IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Tran... There was an error on the outer labeling of this device. The inner label was correct. Class II IDEV Technologies, Inc.
May 29, 2012 AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an ... The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... Class I Carefusion 2200 Inc
May 29, 2012 Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a... GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis... Class II GE Healthcare, LLC
May 29, 2012 AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated;... The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... Class I Carefusion 2200 Inc
May 29, 2012 AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; ... The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... Class I Carefusion 2200 Inc
May 29, 2012 EasyLink Informatic System is included with the Dimension Vista System. The ... When using the EasyLink Quality Control Package the system may not perform as intended for Multi-... Class II Siemens Healthcare Diagnostics, Inc.
May 29, 2012 Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TR... Cracks can arise on the welded seam on the rear joint. Class II Trumpf Medical Systems, Inc.
May 29, 2012 Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG K... Certain pediatric arterial cannulas may have limited flexibility due to an increased length of th... Class II Maquet Inc.
May 25, 2012 GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Vie... Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safe... Class II GE Healthcare, LLC
May 25, 2012 Getinge brand --- large capacity, floor loading jet spray, washers for mechan... Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heate... Class II Getinge USA Inc
May 25, 2012 Alaris PC unit model 8015 Product Usage: The device is labeled for prescr... The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit pow... Class I CareFusion 303, Inc.
May 24, 2012 GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advanta... GE Healthcare has become aware of an issue associated with the magnification images acquired on n... Class II GE Healthcare, LLC
May 24, 2012 Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, ... Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10... Class II Ultradent Products, Inc.
May 24, 2012 GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.... GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol o... Class II GE Healthcare, LLC
May 24, 2012 AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 516009... It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, t... Class II GE Healthcare, LLC
May 24, 2012 EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118;... EKOS Corporation have recently received several complaints from users where the radio-opaque mark... Class II EKOS Corporation
May 24, 2012 GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 an... GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdv... Class II GE Healthcare, LLC
May 24, 2012 GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View... GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT... Class II GE Healthcare, LLC
May 23, 2012 Intellispace Portal software. Intellispace Portal is a multimodality thin ... Philips is issuing a software update to the Intellispace Portal systems to address a number of no... Class II Philips Medical Systems (Cleveland) Inc
May 23, 2012 LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device... The recall was initiated because LMANA has received a complaint that the Esophageal Intubation De... Class II LMA North America Inc
May 23, 2012 Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instru... On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due ... Class II Stingray Surgical Products, LLC
May 23, 2012 Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(... The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal co... Class II Integra Limited
May 23, 2012 IntelliSpace Portal software and Extended Brillance Workspace software In... The Intellispace Portal software and Extended Brillance Workspace software may have significantly... Class II Philips Medical Systems (Cleveland) Inc
May 22, 2012 BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in pa... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 66070... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 22, 2012 Intellispace Portal software Product Usage: Intellispace Portal is a mult... In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using ... Class II Philips Medical Systems (Cleveland) Inc
May 22, 2012 BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part**... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***G... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determinat... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 22, 2012 BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***Gene... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 includ... With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirro... Class II Philips Healthcare Inc.
May 22, 2012 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 22, 2012 Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 22, 2012 TetraCXP Software System, Part Number A40051. Allows simultaneous identifi... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 22, 2012 Alere Triage Profiler SOB Panel PN 97300 Used for the determination of cre... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, 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.