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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

Infrastructure

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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
Jun 11, 2014 Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended... Loosened monitor arm. Class II Hitachi Aloka Medical, Ltd.
Jun 11, 2014 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DAT... Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow ... Class I GE Healthcare, LLC
Jun 11, 2014 Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED... LED battery chargers may prematurely fail and will not charge the LED battery as intended Class II Integra LifeSciences Corp.
Jun 10, 2014 Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral C... A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an e... Class II Zimmer, Inc.
Jun 10, 2014 Tenor is a mobile passive lift, intended to be used on horizontal surfaces fo... ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke durin... Class II ARJOHUNTLEIGH POLSKA SP. ZO.O.
Jun 10, 2014 EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... Class II Baxter Healthcare Corp.
Jun 10, 2014 Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was inco... Class II Animas Corporation
Jun 9, 2014 Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal ... An oversight in the implementation of the design change record resulted in outdated components be... Class II Arthrosurface, Inc.
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufact... Laser aperture label was not affixed to device prior to shipment in the US. Class II Nidek Inc
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Sie... The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to altern... Class II Siemens Healthcare Diagnostics Inc.
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: ... Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for... Class II Nidek Inc
Jun 9, 2014 MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60... Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees of... Class II Integra LifeSciences Corp.
Jun 9, 2014 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These device... Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product con... Class II 3M Company - Health Care Business
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 6, 2014 Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert ... Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of... Class II Spacelabs Healthcare Inc
Jun 6, 2014 Philips Medical System Allura Xper X-Ray Angiographic In certain circumstances, a software error can lead to a situation where the five minute fluorosc... Class II Philips Medical Systems, Inc.
Jun 6, 2014 BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer ... Laser cooling fans and internal fan of the associated fluidics cart are not operational. Class II BD Biosciences, Systems & Reagents
Jun 6, 2014 CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an en... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
Jun 6, 2014 Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a g... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
Jun 6, 2014 TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar ... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
Jun 6, 2014 The Hospira MedNet Medication Management Suite (MMS). Product Usage: The ... Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg... Class II Hospira Inc.
Jun 6, 2014 AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicate... When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize... Class II AGFA Corp.
Jun 5, 2014 Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory ... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee /... There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2014 DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall... There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing d... Class II Briggs Medical Service Company d.b.a. Mabis
Jun 5, 2014 Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory g... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 320... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... Class II Argon Medical Devices, Inc
Jun 5, 2014 Calcium Hydroxide Powder, USP For use in root canal therapy by health care... One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed... Class II Axcentria Pharmaceuticals, LLC
Jun 5, 2014 Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Tripl... There is a potential for a leak. A molding defect in the connector that joins the three leads t... Class II Excelsior Medical Corp
Jun 5, 2014 Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas h... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory g... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respi... The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentiall... Class II Teleflex Medical
Jun 5, 2014 Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier ... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory ga... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 3... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... Class II Argon Medical Devices, Inc
Jun 5, 2014 Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory g... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humid... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humi... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... Class II Argon Medical Devices, Inc
Jun 5, 2014 Artis zee and Artis zeego systems. x-ray, angiographic system There is a potential problem with Artis zee and Artis zeego systems running software version VC21... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2014 Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas ... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 5, 2014 Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respi... The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class II Teleflex Medical
Jun 4, 2014 InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, ... Stryker has received complaints from the field alleging instances where the In Touch beds are hoi... Class II Stryker Medical Division of Stryker Corporation

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.