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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

3,235 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,235 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 3,235 FDA device recalls.

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DateProductReasonClassFirm
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 ¿-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 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 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 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 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 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 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 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 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 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 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 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 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 3, 2025 A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and... Complaints received that Vanta A71200 CP App does not function as intended during use. There is a... Class II Medtronic Neuromodulation
Dec 3, 2025 BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1... Due a software issue that may result in equipment not receiving timely updates of patient, medica... Class II CareFusion 303, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStatio... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. S... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as intended for certai... Class II RAYSEARCH LABORATORIES AB
Nov 24, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... Ophthalmic procedure packs may have incomplete seals affecting sterility. Class I Alcon Research LLC

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.