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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

35,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,653 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 35,653 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PA... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 11, 2025 Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 There is the potential for extended length of the blade obturator after assembly into the cannula... Class II Applied Medical Resources Corp
Dec 11, 2025 Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 8155... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 The product is used for the evaluation of the intrinsic coagulation pathway, ... Potential for microbial contamination. Class II Instrumentation Laboratory
Dec 11, 2025 Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: ... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, Inc.
Dec 11, 2025 NexxZr T Multi A3.5 W98-16mm, REF: 745451 Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have redu... Class II Sagemax Bioceramics, Inc.
Dec 10, 2025 Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin ... Some of the Calibration/Output Certificates had the outputs reversed. Class II Daavlin Distributing Company
Dec 10, 2025 MOSAIQ Oncology Information System with Particle Therapy License (License Ki... Using oncology information system that manages workflow may result in overtreatment if:Plan deliv... Class II Elekta, Inc.
Dec 10, 2025 SMV DSI, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a ... Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical b... Class II REPLIGEN CORPORATION
Dec 10, 2025 MAXXUS, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 Mazor X robotic guidance system REF: TPL0059 Software errors that can result in incorrect surgical instrument positioning during spinal surgery. Class II Mazor Robotics Ltd
Dec 10, 2025 SMV DSX New Line, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 SMV BodyTrack, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 9, 2025 Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vi... Due to increased complaints for broken/frayed grip cables for reusable instruments. Class II Intuitive Surgical, Inc.
Dec 9, 2025 Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vi... Due to increased complaints for broken/frayed grip cables for reusable instruments. Class II Intuitive Surgical, Inc.
Dec 9, 2025 Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: d... Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instr... Class II Intuitive Surgical, Inc.
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 ... increase of complaints regarding the breakage of the ampoules within their device systems. An ext... Class II Heraeus Medical GmbH (Dental Division)
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/... increase of complaints regarding the breakage of the ampoules within their device systems. An ext... Class II Heraeus Medical GmbH (Dental Division)
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Mode... increase of complaints regarding the breakage of the ampoules within their device systems. An ext... Class II Heraeus Medical GmbH (Dental Division)
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Mo... increase of complaints regarding the breakage of the ampoules within their device systems. An ext... Class II Heraeus Medical GmbH (Dental Division)
Dec 9, 2025 Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name... Due to increased complaints for broken/frayed grip cables for reusable instruments. Class II Intuitive Surgical, Inc.
Dec 9, 2025 Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Nam... Due to increased complaints for broken/frayed grip cables for reusable instruments. Class II Intuitive Surgical, Inc.
Dec 9, 2025 Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vin... Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instr... Class II Intuitive Surgical, Inc.
Dec 8, 2025 Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1... Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo... Class II Securitas Healthcare LLC
Dec 8, 2025 Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version:... Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo... Class II Securitas Healthcare LLC
Dec 8, 2025 The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a... Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim list... Class II Beckman Coulter Ireland, Inc.
Dec 8, 2025 Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog ... Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stab... Class II IMRIS Imaging Inc
Dec 8, 2025 Philips Azurion Systems R3.0. Includes the following label descriptions and c... Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 5, 2025 BVI Leos Laser and Endoscopy System. Model Number: OME6000U. Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nu... Class II Beaver-Visitec International, Inc.
Dec 5, 2025 Revogene C. difficile, in vitro diagnostic assay intended for use with the Re... The affected lots show a decline in performance over time, which may lead to false-negative results. Class II Meridian Bioscience Inc
Dec 5, 2025 LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software ve... Class II Siemens Medical Solutions USA, Inc
Dec 5, 2025 Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Numbe... Incorrect expiration date Class II LimFlow, Inc.
Dec 4, 2025 Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C... AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. Class II Mobius Imaging, LLC
Dec 4, 2025 Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07... Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model... Due to probe bags that may have a compromised or incomplete sterile pouch seal. Class II Intuitive Surgical, Inc.
Dec 4, 2025 Allwell Angioplasty Pack REF: IS-30-B1/B Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. Device packaged in incorrect outer box carton. Class II Abiomed, Inc.
Dec 4, 2025 Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210... Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed a... Class II Medtronic Inc
Dec 4, 2025 Allwell Inflation Device, for angiographic use REF: IS-30-A Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K... Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C... AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. Class II Mobius Imaging, LLC
Dec 4, 2025 Merit Medical , Custom Manifold Kit REF: K09-13203A Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Number... Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, 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.