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Browse Device Recalls

79 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 79 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 79 FDA device recalls.

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DateProductReasonClassFirm
Mar 25, 2019 Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energiza... Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electr... Class II Philips Medical Systems Nederlands
Feb 19, 2019 Foot Switches used with the following systems: 722001 Allura Xper FD 10 C ... Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc... Class II Philips Medical Systems Nederlands
Feb 19, 2019 Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ... Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonan... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imagi... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imagi... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging ... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonanc... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imag... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Ima... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Res... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Reson... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resona... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance ... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imag... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imag... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands

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.