Browse Device Recalls
1,000 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,000 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 1,000 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 26, 2021 | Optima MR450w 1.5T nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | SIGNA Pioneer nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 12, 2021 | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image proce... | A software anomaly exists in the Centricity Universal Viewer study management feature in which st... | Class II | GE Healthcare, LLC |
| Aug 6, 2021 | Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that di... | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive | Class II | GE Healthcare, LLC |
| Aug 6, 2021 | Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that ... | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive | Class II | GE Healthcare, LLC |
| Aug 2, 2021 | Flow sensors kept as stand-alone user replaceable spare parts for the GEHC an... | The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t... | Class II | GE Healthcare, LLC |
| Aug 2, 2021 | Flow sensors that may be installed in the following GEHC anesthesia machines:... | The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts t... | Class II | GE Healthcare, LLC |
| Jul 23, 2021 | Merge Hemo, Software packages 10.2, 10.3, and 10.4 | The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2021 | Revolution CT, Revolution CT ES | The accumulated dose is incorrectly displayed in certain situations. There are two situations tha... | Class II | GE Healthcare, LLC |
| Jun 30, 2021 | The system is intended to produce cross-sectional images of the body by compu... | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... | Class II | GE Healthcare, LLC |
| Jun 30, 2021 | Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution ... | The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interve... | Class II | GE Healthcare, LLC |
| Jun 30, 2021 | The system is intended to produce cross-sectional images of the body by compu... | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... | Class II | GE Healthcare, LLC |
| Jun 30, 2021 | Revolution Apex, Revolution CT with Apex Edition | The accumulated dose is incorrectly displayed in certain situations. There are two situations tha... | Class II | GE Healthcare, LLC |
| Jun 30, 2021 | The system is intended to produce cross-sectional images of the body by compu... | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... | Class II | GE Healthcare, LLC |
| Jun 24, 2021 | AMX Navigate Mobile X-Ray System | An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray ... | Class II | GE Healthcare, LLC |
| Jun 14, 2021 | Revolution EVO, Optima CT660, Optima CT680 CT Systems. | Improperly loaded software options may result in additional X -ray radiation exposure to the pati... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Voyager, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner des... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner d... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scan... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA MR380, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance sca... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With ... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Artist, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner des... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| May 21, 2021 | CARESCAPE PDM-Masimo SpO2. Physiological data monitor. | Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power d... | Class II | GE Healthcare, LLC |
| Apr 19, 2021 | Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic... | If a certain sequence of events occur, the pdf test report that belongs to one patient will appea... | Class II | GE Healthcare, LLC |
| Apr 19, 2021 | GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682... | The IGS system can experience a single vertical line defect where the vertical line divides and h... | Class II | GE Healthcare, LLC |
| Apr 19, 2021 | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with... | A software defect was identified where the Image Styles defined by presentation states from CHRS ... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Mar 19, 2021 | Centricity Universal Viewer - Product Usage: intended to assist in the viewi... | When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workfl... | Class II | GE Healthcare, LLC |
| Mar 19, 2021 | Revolution CT | GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimato... | Class II | GE Healthcare, LLC |
| Mar 17, 2021 | Change Healthcare Enterprise Viewer | Change Healthcare has identified an intermittent software defect which may result in an anchor st... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Feb 7, 2021 | NM/CT 850 Nuclear Medicine / CT Scanners | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause... | Class II | GE Healthcare, LLC |
| Feb 7, 2021 | NM/CT 870 DR Nuclear Medicine / CT Scanners | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus... | Class II | GE Healthcare, LLC |
| Feb 7, 2021 | NM/CT 860 Nuclear Medicine / CT Scanners | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus... | Class II | GE Healthcare, LLC |
| Dec 17, 2020 | System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex... | GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E... | Class II | GE Healthcare, LLC |
| Dec 17, 2020 | System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. | GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E... | Class II | GE Healthcare, LLC |
| Dec 10, 2020 | Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General N... | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... | Class II | GE Healthcare, LLC |
| Dec 10, 2020 | GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for genera... | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... | Class II | GE Healthcare, LLC |
| Dec 10, 2020 | GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for genera... | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... | Class II | GE Healthcare, LLC |
| Dec 10, 2020 | GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) ... | GE Healthcare has become aware of a potential safety issue associated with the improper installat... | Class II | GE Healthcare, LLC |
| Dec 10, 2020 | Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Dis... | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... | Class II | GE Healthcare, LLC |
| Dec 10, 2020 | Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 N... | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... | Class II | GE Healthcare, LLC |
| Dec 10, 2020 | GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for ge... | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... | Class II | GE Healthcare, LLC |
| Nov 23, 2020 | Revolution CT with Apex Edition CT System - Product Usage: intended for head,... | A potential for protocol(s) with unintended patient orientation or scan setting when using Intel... | 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.