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Browse Device Recalls

969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 969 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 969 FDA device recalls.

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DateProductReasonClassFirm
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
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 30, 2014 Merge Hemo software. Merge Hemo monitors, measures, and records physiolog... The application may crash during the cath lab procedure. Class II Merge Healthcare, Inc.
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 3, 2014 The Centricity PACS Workstation is intended for use as a primary diagnostic a... It has been identified that in a reject image workflow where multiple studies are simultaneously ... Class II GE Healthcare
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
Apr 2, 2014 Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM pa... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared ... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare

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.