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

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Dec 12, 2023 VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 ... Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clott... Class II Greiner Bio-One North America, Inc.
Dec 12, 2023 High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx On... Due to an assembly error within the breathing circuit, their pressure output of the breathing cir... Class I Percussionaire Corporation
Dec 12, 2023 Philips Azurion system, Interventional fluoroscopic x-ray system. System P... System may exhibit a loss of imaging functionality and data due to an issue which can cause the s... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 11, 2023 Flow-i C40 Anesthesia System, model 6677400 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-i C30 Anesthesia System, model 6677300 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, pre... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON... There is the potential for incomplete staple line formation during the firing sequence, without m... Class II Ethicon Endo-Surgery Inc
Dec 11, 2023 Flow-e Anesthesia System, model 6887900 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prep... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Flow-i C20 Anesthesia System, model 6677200 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, a... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 BrainFeedback Pro 2 Device - is intended as an instrument that provides a vis... Neurofeedback systems removed due to missing design and development documentation and devices may... Class II RONAN MEDICAL LLC
Dec 11, 2023 Flow-c Anesthesia System, model 6887700 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat... The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe... Class II Olympus Corporation of the Americas
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023 XScribe Cardiac Stress Testing System, version 6, with below product names an... Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... Class II Baxter Healthcare Corporation
Dec 8, 2023 Q-Stress Cardiac Stress Testing System, version 6, with below product name / ... Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... Class II Baxter Healthcare Corporation
Dec 8, 2023 Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reu... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Dec 8, 2023 Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Dec 8, 2023 Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Dec 8, 2023 Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Elec... Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
Dec 8, 2023 WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Deskto... Following an FDA-issued Warning Letter, the firm requested return of their research EEG system co... Class II WAVi Co.
Dec 8, 2023 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... Loss of connectivity between the FlexArm and the Table due to a software issue. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023 XScribe CP Cardiac Stress Testing System, version 6, with below product names... Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... Class II Baxter Healthcare Corporation
Dec 8, 2023 Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope ... Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result ... Class II Olympus Corporation of the Americas
Dec 7, 2023 Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2... During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 7, 2023 ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGP... Class I Globus Medical, Inc.
Dec 7, 2023 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num... During internal review of Polaris battery assembly data from the HiPot operation, a test systems ... Class II Medtronic Inc.
Dec 7, 2023 Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco... Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distrib... Class II TERRAGENE S.A.
Dec 7, 2023 Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray Syste... If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily ope... Class II Philips North America
Dec 7, 2023 Terragene Bionova PCD (PCD222-C) Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distrib... Class II TERRAGENE S.A.
Dec 7, 2023 MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Numb... The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static ... Class II Cook Medical Llc
Dec 6, 2023 Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC12... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Accure Laser System, Model: PFMS00004 Laser system's spot tracking system may become misaligned resulting in the possible risk of deliv... Class II Accure Acne, Inc
Dec 6, 2023 Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5m... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) P... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, ... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Impella Connect, software portal for online device management that allows cli... The following features have been disabled from the web-based portal because the FDA has not evalu... Class II Abiomed, Inc.
Dec 6, 2023 Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 15... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: ... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 9340... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG04... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare 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.