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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Jun 27, 2016 V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill ho... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 24, 2016 Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-... Potential coating contamination with glass particles. Class I Cook Inc.
Jun 24, 2016 Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC... Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing. Class II Moller Vital
Jun 24, 2016 BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tub... One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to a... Class II Becton, Dickinson and Company, BD Biosciences
Jun 24, 2016 Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:... There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 24, 2016 Light Adaptor for Small Battery Drive and Small Battery Drive II. There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 24, 2016 Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-steriliz... Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inac... Class II PerkinElmer, Inc
Jun 24, 2016 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUA... Class II Baxter Healthcare Corp.
Jun 24, 2016 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting acc... A variation in flute depth on the routers was observed. The variation in flute depth may cause th... Class II Stryker Instruments Div. of Stryker Corporation
Jun 24, 2016 Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a sing... The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year... Class II Danville Materials, Inc.
Jun 23, 2016 EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60... Incorrect CO2 readings with some patient monitors. Class II Edan Diagnostics
Jun 23, 2016 Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6... Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis reveal... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2016 Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 Container fill and transfer sets, 250 mL and 500 mL, . . An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 Syngo.via, picture archiving and communications system software controlled. ... Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018... Class II Siemens Medical Solutions USA, Inc
Jun 23, 2016 Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 125... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 6400... Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Mod... Class II Medtronic Neuromodulation
Jun 23, 2016 Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, ... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product... Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increase... Class II Philips Medical Systems Nederlands
Jun 23, 2016 Optical Surface Monitoring System{Align RT Plus} This is used on Varian's Tru... Varian Medical Systems has received reports that unintended changes were made to planned couch p... Class II Varian Medical Systems, Inc.
Jun 23, 2016 OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when usi... Class II Olympus Corporation of the Americas
Jun 23, 2016 Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring,... Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used... Class II Mindray DS USA, Inc. dba Mindray North America
Jun 23, 2016 Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on... Varian Medical Systems has received reports that unintended changes were made to planned couch pa... Class II Varian Medical Systems, Inc.
Jun 23, 2016 Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Seconda... It was reported that the secondary locking mechanism, and its corresponding components, disassoci... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2016 Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, ... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 AUTOCOMP6 XP High Speed Compounder REF 58810 An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 AUTOCOMP6 High Speed Compounder An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 AUTOCOMP6 XPS High Speed Compounder REF 58810 An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 22, 2016 AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Cl... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Cl... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 2... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... Software defect, where either an Above Assay Range or an inaccurate value could potentially be re... Class II Siemens Healthcare Diagnostics Inc
Jun 22, 2016 Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip ... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select T... Incorrect top label on an implant package. Class II Nobel Biocare Usa Llc
Jun 22, 2016 Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip C... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For ... The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the a... Class III Ortho-Clinical Diagnostics
Jun 22, 2016 Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip ... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical ... Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in tes... Class II Olympus Scientific Solutions Americas
Jun 22, 2016 AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary ... Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the ... Class II Sorin Group USA, Inc.
Jun 22, 2016 Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part o... Devices were incorrectly programmed during manufacturing therefore depressing the pendant button ... Class II Stanley Security Solutions Inc
Jun 22, 2016 Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip C... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... Risk associated with operating the device in skin temperature mode with temperature sensors attac... Class II Draeger Medical, Inc.
Jun 22, 2016 Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... The Positive Control information referencing human plasma as the antibody material described in t... Class III 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.