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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,006 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,006 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 1,006 FDA device recalls.

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DateProductReasonClassFirm
Aug 7, 2017 Merge Unity software, formerly known as DR Systems Unity PACS software. The ... The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... Class II Merge Healthcare, Inc.
Jun 13, 2017 Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution fo... When the user has not set up any user preference on the sorting order to render the study images ... Class II Merge Healthcare, Inc.
May 24, 2017 Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha... Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... Class II Merge Healthcare, Inc.
May 24, 2017 Merge OrthoPACS software. A migrated study that has annotations will display the annotations, but when a prior study is loa... Class II Merge Healthcare, Inc.
May 19, 2017 GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX ... It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Revolution EVO X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT660, CT680 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery NM/CT 670 CZT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery Ml X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Lightspeed RT16 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare LightSpeed VCT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery IQ X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT540 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery Ml DR X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery NM/CT 570c X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare BrightSpeed X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare lnnova IGS 540 ACT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT520 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 15, 2017 Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-0... Potential for electric shock in the case of a failure to install the grommets, supplied with the ... Class II Perkinelmer Life Sciences, Inc.
May 8, 2017 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk... Class II Merge Healthcare, Inc.
May 8, 2017 Merge PACS software. Merge PACS (Picture Archiving Communication System) is... When cut lines are shown on an image, the lines may go from being vertical and then shift to hori... Class II Merge Healthcare, Inc.
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

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.