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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

Consumer Safety

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

983 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 983 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 983 FDA device recalls.

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DateProductReasonClassFirm
May 5, 2017 Infant Warmer System (IWS) GE Healthcare has recently become aware of a potential safety issue related to loose screws in t... Class II GE Healthcare, LLC
May 2, 2017 Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction Class II GE Healthcare, LLC
Apr 6, 2017 Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power s... Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLi... Class II Merge Healthcare, Inc.
Mar 10, 2017 Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly... Class II GE Healthcare, LLC
Mar 10, 2017 Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly... Class II GE Healthcare, LLC
Feb 6, 2017 Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems Reported incidents of a patient step detaching from the table. A fall from a patient step detach... Class II GE Healthcare, LLC
Jan 23, 2017 Merge LIS A defect in the software resulted in medications that are not associated with the patient (i.e., ... Class II Merge Healthcare, Inc.
Jan 20, 2017 Discovery MR450 The systems are whole body magnetic resonance scanners des... Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI.... Class II GE Healthcare, LLC
Dec 27, 2016 OEC 9800. MDL Numbers: D222250, D141598 GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ... Class II GE OEC Medical Systems, Inc
Dec 27, 2016 OEC 9900 Elite. MDL Numbers: D148942, D155043 GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ... Class II GE OEC Medical Systems, Inc
Dec 19, 2016 The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluorosco... GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... Class II GE OEC Medical Systems, Inc
Dec 19, 2016 OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile ... GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... Class II GE OEC Medical Systems, Inc
Dec 19, 2016 OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide ... GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... Class II GE OEC Medical Systems, Inc
Dec 9, 2016 Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStat... This recall has been initiated due to an issue related to the potential accidental deletion of re... Class II Merge Healthcare, Inc.
Dec 9, 2016 Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinSt... Merge received reports of Merge Eye Station being unable to capture images of the eye as expected... Class II Merge Healthcare, Inc.
Nov 21, 2016 Prestige II GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 SFX GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 ADVANTX LCN+ GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 ADVANTX LCLP+ GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 Legacy GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 Innova 2000 GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 Prestilix GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 ADVANTX LCV+ GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 RFX GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 Prestige SI GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 ADVANTX LCA GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 Precision 500D GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 21, 2016 Prestige VH GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2,... Class II GE Healthcare, LLC
Nov 3, 2016 GE Healthcare, Avance, Avance CS2, Amingo. GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and A... Class II GE Healthcare, LLC
Oct 20, 2016 Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a... A product issues happens for RF projection images. If user measures on RF image, .cal (Calibratio... Class II Merge Healthcare, Inc.
Sep 23, 2016 OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Produc... GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 6... Class II GE OEC Medical Systems, Inc
Sep 16, 2016 Brivo XR385, model 5215463, Digital Diagnostic Radiographic System The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can i... Class II GE Healthcare, LLC
Aug 31, 2016 GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involv... Class II GE Healthcare, LLC
Aug 4, 2016 Infant Warmer System (IWS) GE Healthcare has recently become aware of a potential safety issue related to loose screws in th... Class II GE Healthcare, LLC
Jul 14, 2016 Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30... It was reported by a customer that RadSuite images are not appearing as readable images. Thi... Class II Merge Healthcare, Inc.
Jun 8, 2016 GE Healthcare, Discovery MR750w GE Healthcare has recently become aware of a potential safety issue with the patient bore heating... Class II GE Healthcare, LLC
May 25, 2016 iConnect Access software. The firm name on the label is Merge Healthcare, Ha... Software displayed incorrect prior reports in the viewport area, only when more than one prior st... Class II Merge Healthcare, Inc.
May 9, 2016 Optima 1.5T MR430s MR Scanner, a diagnostic imaging device The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti... Class II GE Healthcare, LLC
May 9, 2016 MSK 1.5T Extreme MR Scanner, a diagnostic imaging device The gas venting may not occur properly. A site reported a magnet quenching with subsequent venti... Class II GE Healthcare, LLC
May 9, 2016 GE Revolution CT The system is intended for head, whole body, cardiac and ... GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can res... Class II GE Healthcare, LLC
Apr 15, 2016 GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscop... Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... Class II GE Medical Systems, LLC
Apr 15, 2016 Merge LIS software. The firm name on the label is Merge Healthcare. Merge... There are potential issues with results reporting for certain run-based tests. Under certain con... Class II Merge Healthcare, Inc.
Apr 15, 2016 GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscop... Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... Class II GE Medical Systems, LLC
Apr 13, 2016 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... Fetal patient report was automatically pulling prior measurement data for a prior fetus since the... Class II Merge Healthcare, Inc.
Apr 8, 2016 DR Systems Unity PACS software, now known as Merge Unity PACS Reports were missing demographic header information when they were faxed to referring physicians. Class II Merge Healthcare, Inc.
Apr 8, 2016 DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usa... The software is not adding the correct tomo image. Class II Merge Healthcare, Inc.
Apr 4, 2016 Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitor... In some instances, the system will lock tabs within a study, even when a second user does not hav... Class II Merge Healthcare, Inc.
Apr 4, 2016 MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part ... Under certain conditions, the cables used with the Hemo system during a patient procedure could s... Class II Merge Healthcare, Inc.
Apr 4, 2016 iConnect Enterprise Archive software. The versions allow images to be stored without pixel data, resulting in the system not being able... Class II Merge Healthcare, Inc.
Apr 4, 2016 iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is ... The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting i... Class II Merge 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.