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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

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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

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

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DateProductReasonClassFirm
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 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 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.
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 3, 2025 Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1... Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Per... Class II Boston Scientific Corporation
Dec 3, 2025 Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW versio... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. ... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. ... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW ve... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. ... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW v... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR s... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
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 3, 2025 Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW versio... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Philips Incisive CT Potential for incomplete scan due to unstable connection inside of floating sensor. Class II Philips Healthcare (Suzhou) Co., Ltd.
Dec 3, 2025 SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
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 LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo... Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... Class II Microbiologics Inc
Dec 2, 2025 KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... Class II Microbiologics 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 KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... Class II Microbiologics 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 29, 2025 BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Fem... Labeling error, Incorrect expiration date Class II HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
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 SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Certain pumps have potentially been released from service with defective grease applied to the ca... Class II Baxter Healthcare Corporation
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

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.