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Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
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 VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthe... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
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 VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia ... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
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 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
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 Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 The products were manufactured with longer than specified sheaths. Class II Cook Inc.
Dec 21, 2018 VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthe... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
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
Dec 21, 2018 Multiva 1.5T 8 R5, Model Number 781074. 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 Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... Class II Zimmer Biomet, Inc.
Dec 21, 2018 Achieva 3.0T TX, Model Number 781345. 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 ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product ... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 21, 2018 Intera Achieva 1.5T Nova Dual, Model Number 781173. 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 Multiva 1.5T 8 R5 (ZBO), Model Number 781072. 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 VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia S... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 Intera 1.5T Explorer/Nova Dual, Model Number 781108. 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 Conversion, Model Number 781283. 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 Intera Achieva 1.5T Nova, Model Number 781172. 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 VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Ane... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesi... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 Achieva 1.5T, Model Number 781296. 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 MR RT, Model Number 781439. 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 3.0T, Model Number 781342. 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 X, Model Number 781358. 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 Intera 1.0T Power/Pulsar, Model Number 781103. 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 SmartPath to dStream for 1.5T, Model Number 781260. 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 Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper A... The product was potentially being packaged without a taper adapter. Class II Zimmer Biomet, Inc.
Dec 21, 2018 Enterprise 1.5T, Model Number 781145. 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 Achieva CV Nova, Model Number 781174. 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 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 21, 2018 SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic... 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 781153. 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 20, 2018 The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DC... Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds... Class II Merge Healthcare, Inc.
Dec 20, 2018 Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 Presence of natural rubber latex is not declared in the label Class II Terumo Cardiovascular Systems Corporation
Dec 20, 2018 Phoenix AST-s Indicator, Catalog Number 246009 Panels inoculated using certain lots of the indicator solution are demonstrating an increased occ... Class II Becton Dickinson & Co.

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.