Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 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 474 FDA device recalls.

Clear
DateProductReasonClassFirm
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 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
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
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
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 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
Oct 14, 2014 GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H... GE is issuing this recall due to a potential safety issue related to a portion of the system fall... Class II GE Healthcare, LLC
Oct 14, 2014 GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infini... GE is issuing this recall due to a potential safety issue related to a portion of the system fall... Class II GE Healthcare, LLC
Oct 14, 2014 Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy... GE is issuing this recall due to a potential safety issue related to a portion of the system fall... Class II GE Healthcare, LLC
Oct 14, 2014 Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima... GE is issuing this recall due to a potential safety issue related to a portion of the system fall... Class II GE Healthcare, LLC
Oct 14, 2014 Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy... GE is issuing this recall due to a potential safety issue related to a portion of the system fall... Class II GE Healthcare, LLC
Oct 14, 2014 Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst... GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preve... Class II GE Healthcare, LLC
Sep 19, 2014 GE Healthcare Carescape Patient Data Module GE Healthcare has recently become aware of a potential safety issue to the ECG calculations foll... Class II GE Healthcare, LLC
Sep 5, 2014 GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Pr... GE Healthcare has become aware of a potential safety issue involving missing screws used for moun... Class II GE Healthcare, LLC
Sep 4, 2014 Innova 4100IQ Indicated for use in generating fluoroscopic images of human... Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... Class II GE Healthcare, LLC
Sep 4, 2014 Discovery IGS 740 Indicated for use for patients from newborn to geriatric... Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... Class II GE Healthcare, LLC
Sep 4, 2014 Innova IGS 540 Indicated for use for patients from newborn to geriatric in... Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... Class II GE Healthcare, LLC
Aug 8, 2014 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-s... GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sen... Class II GE Healthcare, LLC
Jul 25, 2014 GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate dig... GE Healthcare has become aware of a potential safety issue involving the nylon hooks which suppor... Class II GE Healthcare, LLC
Jul 7, 2014 GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor inte... Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is conn... Class II GE Healthcare, LLC
Jun 13, 2014 GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PD... Class II GE Healthcare, LLC
Jun 11, 2014 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DAT... Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow ... Class I GE Healthcare, LLC
Jun 4, 2014 GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for us... GE Healthcare has become aware of a potential safety issue due to a collimator installation error... Class II GE Healthcare, LLC
Jun 4, 2014 GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolut... GE Healthcare has become aware of a potential safety issue due to a collimator installation error... Class II GE Healthcare, LLC
May 23, 2014 GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV an... Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the ga... Class II GE Healthcare, LLC
May 2, 2014 Kenex Radiation Shield and surgical lamps installed with GE Healthcare Inter... GE Healthcare has recently become aware of a potential safety issue due to the improper installat... Class II GE Healthcare, LLC
Apr 23, 2014 GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w ... GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products.... Class II GE Healthcare, LLC
Apr 9, 2014 GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: ... When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmi... Class II GE Healthcare, LLC
Apr 7, 2014 GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 ... GE Healthcare has recently become aware of a potential safety issue due to higher than actual flo... Class II GE Healthcare, LLC
Apr 2, 2014 GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450... Potential safety issue with gradient coil electromechanical connections associated with GE MR Pro... Class II GE Healthcare, LLC
Mar 27, 2014 GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specializ... GE Healthcare has recently become aware of a potential safety issue where the probe power surveil... 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.