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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

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
Jul 14, 2016 STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Int... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 14, 2016 Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number... Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incor... Class II Straumann Manufacturing, Inc.
Jul 14, 2016 Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Mi... Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile pac... Class II Ecolab Inc
Jul 14, 2016 CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Sur... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urolo... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 14, 2016 STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The ... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identi... Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagen... Class II ORTHO-CLINICAL DIAGNOSTICS
Jul 14, 2016 MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specifi... There is a possibility of low volume and/or leaking standard bottles. Class II Diagnostic Hybrids, Inc.
Jul 14, 2016 STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Int... Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... Class II Intuitive Surgical, Inc.
Jul 14, 2016 Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30... It was reported by a customer that RadSuite images are not appearing as readable images. Thi... Class II Merge Healthcare, Inc.
Jul 14, 2016 Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Numbe... Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incor... Class II Straumann Manufacturing, Inc.
Jul 14, 2016 STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intu... An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... Class II Intuitive Surgical, Inc.
Jul 13, 2016 SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 co... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, c... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol... DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. ... Class II Diasorin Inc.
Jul 13, 2016 AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Ar... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa... A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa... Class II AccessClosure, Inc., A Cardinal Health Company
Jul 13, 2016 SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, co... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / ze... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic ... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 12, 2016 Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: Th... Software malfunction; The action being taken due to the device becoming inoperable due to softwa... Class III ELITech Group B.V.
Jul 12, 2016 Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with... Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain... Class II Resmed Corporation
Jul 12, 2016 McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is... The STAT priority icon was not displayed in the Study List when the study was opened. Class II Mckesson Medical Imaging Group
Jul 11, 2016 Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: ... Possible dull knife edge Class II Bausch & Lomb Inc Irb
Jul 11, 2016 Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 ... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 63... After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away... Class II Ivoclar Vivadent, Inc.
Jul 11, 2016 Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DEx... B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tr... Class II B. Braun Medical, Inc.
Jul 11, 2016 INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Pr... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRa... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 P... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. During an FDA inspection it was found out that the Practical Foley Catheters to be potentially no... Class II C.R. Bard, Inc.
Jul 11, 2016 Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to... Possible dull knife edge Class II Bausch & Lomb Inc Irb
Jul 11, 2016 Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 ... The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator ... Class III Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Jul 11, 2016 Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number ... The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may ... Class II American National Mfg Inc
Jul 11, 2016 Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Str... Class I Alere San Diego, Inc.
Jul 11, 2016 SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK S... The product contained a latex catheter instead of a silicone catheter. Class II C.R. Bard, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A ... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only. During an FDA inspection it was found out that the Practical Foley Catheters to be potentially no... Class II C.R. Bard, Inc.
Jul 11, 2016 Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 10, 2016 Stationary Column TruSystem 7599, Material Number 1717020 Patient position... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jul 10, 2016 Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Colu... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jul 10, 2016 Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSyste... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jul 10, 2016 Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table Tr... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 T... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products... Several customer complaints about amplification performance issues when using different batches o... Class I BioMerieux SA
Jul 8, 2016 Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E2581... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic

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.