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Browse Device Recalls

124 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 124 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 124 FDA device recalls.

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DateProductReasonClassFirm
Oct 30, 2012 Philips Digital Diagnost Stationary radiographic system When the operator for a wall stand view selects an "image rotation" different from default, or su... Class II Philips Healthcare Inc.
Oct 30, 2012 Philips Digital Diagnost Software Version R2.0.2 Product Usage: This syst... With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in ... Class II Philips Healthcare Inc.
Oct 25, 2012 Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers... When the operator for a wall stand view selects an "image rotation" different from default, or su... Class II Philips Healthcare Inc.
Sep 28, 2012 Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... Class II Philips Medical Systems (Cleveland) Inc
Sep 12, 2012 Philips Digital Diagnost with patient carriage Model: 712050 with serial nu... Hook does not securely hold the footplate in vertical position, causing the footplate to disengag... Class II Philips Healthcare Inc.
Sep 11, 2012 Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat... HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with ... Class II Philips Healthcare Inc.
Sep 6, 2012 Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single ... The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and ... Class II Philips Healthcare Inc.
Aug 31, 2012 The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system i... Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causin... Class II Philips Medical Systems (Cleveland) Inc
Aug 21, 2012 Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual ... A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumu... Class II Philips Medical Systems (Cleveland) Inc
Aug 15, 2012 Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ ... Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wa... Class II Philips Healthcare Inc.
Aug 14, 2012 Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary ... Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (... Class II Philips Healthcare Inc.
Jul 25, 2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... Essenta DR C-Arm may fall Class II Philips Healthcare Inc.
Jul 11, 2012 Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642... Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could ... Class II Philips Healthcare Inc.
Jul 11, 2012 Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 ... When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always st... Class II Philips Healthcare Inc.
Jul 2, 2012 Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomog... Philips Healthcare was notified that several of the sixteen bolts securing the brackets which sup... Class II Philips Medical Systems (Cleveland) Inc
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M... HeartStart MRx Unexpected Pads/Paddles ECG Failure Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M35... Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddl... Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 ... Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG Class II Philips Healthcare Inc.
Jun 14, 2012 Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data... Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface Class II Philips Healthcare Inc.
May 22, 2012 Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 includ... With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirro... Class II Philips Healthcare Inc.
May 21, 2012 Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 70... MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement Class II Philips Healthcare Inc.
May 11, 2012 Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured... Class II Philips Healthcare Inc.
Oct 19, 2011 Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribu... When the system is switched off or when the tube arm is parked in the down position (X-ray genera... Class II Philips Healthcare Inc.
Apr 5, 2010 Philips Healthcare Computed Tomography X-Ray System. These devices are who... Philips Healthcare discovered the customer was performing CTDI measurements for facility accredi... Class II Philips Healthcare 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.