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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Nov 23, 2020 | Revolution CT ES - Product Usage: intended for head, whole body, cardiac and ... | A potential for protocol(s) with unintended patient orientation or scan setting when using Intell... | Class II | GE Healthcare, LLC |
| Oct 27, 2020 | MAC VU360, Electrocardiograph | Incorrect patient identification and/or patient demographic errors. | Class II | GE Healthcare, LLC |
| Sep 21, 2020 | Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product U... | There is a potential for a smudge artifact that could be suspect for pathology in some images due... | Class II | GE Healthcare, LLC |
| Sep 17, 2020 | GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to p... | Flow sensors could have damaged tubes in the form of small punctures or cuts. | Class II | GE Healthcare, LLC |
| Sep 17, 2020 | Flow Sensor Service Part, Catalog 2087640-001-S | Flow sensors could have damaged tubes in the form of small punctures or cuts. | Class II | GE Healthcare, LLC |
| Sep 17, 2020 | Flow Sensor Service Part, Catalog 2096513-001-S | Flow sensors could have damaged tubes in the form of small punctures or cuts. | Class II | GE Healthcare, LLC |
| Sep 17, 2020 | GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to pro... | Flow sensors could have damaged tubes in the form of small punctures or cuts. | Class II | GE Healthcare, LLC |
| Sep 17, 2020 | 9100c NXT system - Product Usage: Device is licensed and distributed outside ... | Flow sensors could have damaged tubes in the form of small punctures or cuts. | Class II | GE Healthcare, LLC |
| Sep 17, 2020 | Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia... | Flow sensors could have damaged tubes in the form of small punctures or cuts. | Class II | GE Healthcare, LLC |
| Sep 17, 2020 | Flow Sensor Service Part, Catalog 2089610-001-S | Flow sensors could have damaged tubes in the form of small punctures or cuts. | Class II | GE Healthcare, LLC |
| Sep 8, 2020 | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
| Sep 8, 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
| Sep 8, 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
| Sep 8, 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
| Sep 8, 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM/CT 860, SPECT/CT | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | Discovery 670 DR Model # H3100BT | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM 830 Model # H3910AC | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM/CT 870 CZT Model # H3906CW | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM/CT 870 DR Model # H3100AS | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | Discovery NM670 Pro Model # H3100XB | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | Discovery NM 630 Model # H3101RH | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM/CT 850 Model Number: H3907AD | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Jul 14, 2020 | CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocesso... | The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an ... | Class II | GE Healthcare, LLC |
| Jun 22, 2020 | CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi... | CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if ... | Class II | GE Healthcare, LLC |
| May 18, 2020 | CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCA... | The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/... | Class II | GE Healthcare, LLC |
| Apr 28, 2020 | Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. | Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmenta... | Class II | GE Healthcare, LLC |
| Apr 28, 2020 | Giraffe Incubator with installed Servo Oxygen module. Infant incubator. | Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmenta... | Class II | GE Healthcare, LLC |
| Apr 2, 2020 | Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GT... | During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) prod... | Class II | GE Healthcare, LLC |
| Dec 23, 2019 | SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T... | It was identified that due to a potential installation workflow issue, the MR system date could b... | Class II | GE Healthcare, LLC |
| Dec 23, 2019 | SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a... | It was identified that due to a potential installation workflow issue, the MR system date could b... | 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.