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Browse Device Recalls

421 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 421 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 421 FDA device recalls.

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DateProductReasonClassFirm
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
Apr 23, 2021 Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... Class II Philips North America Llc
Apr 23, 2021 Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated ... The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... Class II Philips North America Llc
Apr 13, 2021 BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to pro... Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury Class II Philips North America Llc
Mar 29, 2021 Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor)... Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of... Class II Philips North America Llc
Feb 22, 2021 Incisive CT Computed Tomography X-ray System Model: 728143 Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2... Class II Philips North America Llc
Feb 9, 2021 Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A Customers were not notified of previous recalls associated with various defibrillator models. Class II Philips North America LLC
Feb 9, 2021 Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A Customers were not notified of previous recalls associated with various defibrillator models. Class II Philips North America LLC
Feb 9, 2021 Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 Customers were not notified of previous recalls associated with various defibrillator models. Class II Philips North America LLC
Feb 9, 2021 Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A Customers were not notified of previous recalls associated with various defibrillator models. Class II Philips North America LLC
Feb 2, 2021 IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Softw... Manufacturing failed to follow process steps resulting in the distribution of potentially defecti... Class II Philips North America Llc
Dec 24, 2020 PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgra... Patient tabletop moved out to the home position during scan initialization, may cause operator/by... Class II Philips North America
Nov 18, 2020 Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usa... Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... Class II Philips North America Llc
Nov 18, 2020 Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended fo... Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... Class II Philips North America Llc
Sep 10, 2019 Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in a... Class II Philips North America LLC
Sep 10, 2019 Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED,... Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in a... Class II Philips North America LLC
Nov 23, 2018 HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which... Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should... Class II Philips North America LLC
Aug 8, 2018 Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:008... The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging ... Class II Philips North America LLC
Jan 29, 2018 Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter i... Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... Class II Philips Electronics North America Corporation
Jan 29, 2018 Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter i... Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... Class II Philips Electronics North America 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.