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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

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 19, 2023 Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medf... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 ... Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replac... Class II Boston Scientific Corporation
Dec 19, 2023 Model A710 Intellis Clinician Programmer Application, version 2.0.97 Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application ... Class II Medtronic Neuromodulation
Dec 19, 2023 Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C7... Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... Class II Beckman Coulter, Inc.
Dec 19, 2023 iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 7... Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... Class II Beckman Coulter, Inc.
Dec 19, 2023 Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD ... Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to ... Class II OriGen Biomedical, Inc.
Dec 19, 2023 iQ Waste Well Adapter, Part Number: 700-3393 Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... Class II Beckman Coulter, Inc.
Dec 19, 2023 Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 ... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 18, 2023 PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H78... Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak du... Class II Angiodynamics, Inc.
Dec 18, 2023 TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F ... When the catheters are used with the EnSiteX EP System, the system does not correctly recognize t... Class II St. Jude Medical, Atrial Fibrillation Division,...
Dec 18, 2023 Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 Reason for the voluntary recall is residue was identified on the two forceps tips of a customer i... Class II Vortex Surgical Inc.
Dec 15, 2023 ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/... Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s ra... Class II Philips North America
Dec 15, 2023 PANTHER FUSION System REF 9121010000 The Panther System is an integrated... Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. Class II Hologic, Inc.
Dec 15, 2023 ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... Devices may not be rendered sterile due to an internal gap that may be present on some devices ca... Class II Globus Medical, Inc.
Dec 15, 2023 ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy... Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients rad... Class II Philips North America
Dec 15, 2023 ESG PK CUTTING FORCEPS, 5MM, 33CM The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or duri... Class II Olympus Corporation of the Americas
Dec 15, 2023 Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Potential for a negative bias with quality control (QC) and patient sample results when using the... Class II Siemens Healthcare Diagnostics, Inc.
Dec 14, 2023 FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only... Their is a potential for false positive results when using Pneumonia panel. Class II BioFire Diagnostics, LLC
Dec 14, 2023 FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IV... Their is a potential for false positive results when using Pneumonia panel. Class II BioFire Diagnostics, LLC
Dec 13, 2023 Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 13, 2023 DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 13... Class II Diasorin Inc.
Dec 13, 2023 Spectral CT on Rails: Software Version 5.1.0.X, model 728334. A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... Class II PHILIPS MEDICAL SYSTEMS
Dec 13, 2023 Sedecal X Optima URS digital mobile diagnostic x-ray system. A a station... Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. Class II SEDECAL SA
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 12, 2023 Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... Class II Steris Corporation
Dec 12, 2023 Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... Class II Steris Corporation
Dec 12, 2023 TECNIS Toric II OptiBlue IOL Models ZCW Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks ... Class II Johnson & Johnson Surgical Vision, Inc.
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 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 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 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 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-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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.

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.