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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 29, 2015 GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in genera... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 4, 2015 GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). The heart rate could be calculated from pacer pulses without indication that pacemaker detection ... Class II GE Healthcare
Apr 24, 2015 D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with... A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fe... Class II GE Healthcare
Apr 22, 2015 CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designe... GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of th... Class II GE Healthcare
Apr 9, 2015 Merge RadSuite software. Radiological image processing system. When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it ... Class II Merge Healthcare, Inc.
Mar 30, 2015 Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-000... The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is ... Class II Merge Healthcare, Inc.
Mar 12, 2015 GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate ... GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of... Class II GE Healthcare
Mar 9, 2015 GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INF... GE Healthcare has become aware of a potential safety issue involving MRI systems due to software ... Class II GE Healthcare
Mar 9, 2015 Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, ... GE Healthcare has recently become aware of an improper installation of a ceiling suspended penden... Class II GE Healthcare
Mar 5, 2015 GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine system... GE Healthcare has recently become aware of a potential safety issue due to a collimator falling o... Class II GE Healthcare
Mar 5, 2015 Merge LIS software. There is a potential for duplicate container numbers to be created for patients. Class II Merge Healthcare, Inc.
Feb 27, 2015 GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers... Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circ... Class II GE Healthcare
Feb 16, 2015 GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbe... Potential safety issue due to improper assembly associated with the power cords of T2100 and T200... Class II GE Healthcare
Jan 30, 2015 GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended ... Potential breakage of the steel cable which supports the bucky device in certain wall stands of P... Class II GE Healthcare
Jan 27, 2015 GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model ... Potential failure of the caster mounting hardware, which may result in the ventilator falling/tip... Class II GE Healthcare
Jan 21, 2015 Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Ma... A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, result... Class II Merge Healthcare, Inc.
Jan 7, 2015 This correction applies to all GE Healthcare MRI systems with superconducting... At certain sites, the MRU may not be connected to the magnet. In emergency situations, a discon... Class I GE Healthcare
Dec 19, 2014 GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner. Potential safety issue due to a required torque check on three bolted joints of the Revolution CT... Class II GE Healthcare
Dec 19, 2014 GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx An issue was identified with the mAs accuracy check performed on the system that could result in ... Class II GE Healthcare
Dec 19, 2014 GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx An issue was identified with the mAs accuracy check performed on the system that could result in ... Class II GE Healthcare
Dec 19, 2014 GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx An issue was identified with the mAs accuracy check performed on the system that could result in ... Class II GE Healthcare
Dec 10, 2014 GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : ... Potential unintentional system motion or rotation due to a positioning user interface issue with ... Class II GE Healthcare
Dec 8, 2014 GE Healthcare, Proteus XR/a with wall stand model number 600-0301. GE Healthcare has recently become aware of a potential safety issue involving the breakage of the... Class II GE Healthcare
Dec 3, 2014 GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electro... The firm discovered that during the use of these defibrillation electrodes a possibility for arci... Class I Leonhard Lang Gmbh
Nov 12, 2014 The Revolution CT is a multi-slice (256 detector row) CT scanner consisting o... A required quality control test was not performed during installation associated with the softwar... Class II GE Healthcare
Oct 24, 2014 GE Discovery MR950 MRI system The alignment lasers are missing the labels required by radiation safety regulations. Class II GE Healthcare
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
Oct 3, 2014 OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to prov... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Oct 3, 2014 OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic an... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Oct 3, 2014 Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic a... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Oct 3, 2014 FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital M... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Sep 29, 2014 Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system ... It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update... Class II Merge Healthcare, Inc.
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 28, 2014 eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components ... There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studie... Class II Merge Healthcare, Inc.
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

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.