Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 27, 2018 ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for ... Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. Class II Synvasive Technology Inc
Jul 25, 2018 Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Pro... There was a potential that a 25-gauge infusion cannula may be included within the procedure pak i... Class II Alcon Research LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning Sterilization Protocol for Trillia... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 16, 2018 Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 1... The product was mislabeled as containing the incorrect type of suture. Class II Valeris Medical, LLC
Jul 13, 2018 Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 86... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... The product was mislabeled with the incorrect label. Class III Smiths Medical ASD Inc.
Jul 13, 2018 Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns V... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central m... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 12, 2018 Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk... Dental varnish has the possibility of having an unpleasant and off flavor. Class II Ultradent Products, Inc.
Jul 10, 2018 djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S... The retaining ring on the neck trials has a potential to fail interoperatively. Class II Encore Medical, LP
Jul 9, 2018 Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product U... INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expi... Class II INO therapeutics LLC/dba ikaria
Jul 6, 2018 smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas... "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... Class III Smiths Medical ASD Inc.
Jul 6, 2018 smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Ti... "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... Class III Smiths Medical ASD Inc.
Jul 6, 2018 smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas... "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... Class III Smiths Medical ASD Inc.
Jul 6, 2018 smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flare... "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... Class III Smiths Medical ASD Inc.
Jul 6, 2018 smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Fl... "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... Class III Smiths Medical ASD Inc.
Jul 3, 2018 Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... Vials labeled for the prescriptions contained incorrect lenses Class III Alden Optical
Jul 3, 2018 Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip AR... One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter.... Class II Arrow International Inc
Jul 3, 2018 Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... Vials labeled for the prescriptions contained incorrect lenses Class III Alden Optical
Jun 29, 2018 Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could... Class II Luminex Corporation
Jun 29, 2018 Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B P... Packages labeled as containing 110mm rods may contain 100mm rods. Class II Back 2 Basics Direct LLC
Jun 28, 2018 Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes... Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than... Class II Envoy Medical Corporation
Jun 27, 2018 Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device i... Genicon is providing updated IFU labeling to users to provide clarity on how to use the device fo... Class II Genicon, Inc.
Jun 25, 2018 This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and... The device accessories were not labeled with appropriate latex warning. Class II DJO, LLC
Jun 22, 2018 Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial B... The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... Class II Smiths Medical ASD Inc.
Jun 22, 2018 Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: ... Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for u... Class III Clarity Diagnostics Llc
Jun 22, 2018 Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial B... The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... Class II Smiths Medical ASD Inc.
Jun 21, 2018 Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KOD... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential ... Class II DePuy Orthopaedics, Inc.
Jun 21, 2018 Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skul... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERIL... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERIL... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pi... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 20, 2018 Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO... Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it sh... Class II Espiner Medical Ltd
Jun 19, 2018 VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108... Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver Class II Vascular Technology, Inc.
Jun 19, 2018 NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ... Mislabeled hook pouch included a transport/storage label rather than the product label containin... Class II Nico Corp.

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.