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 |
|---|---|---|---|---|
| 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 25, 2020 | Change Healthcare Radiology Solutions 14.0 | Software defect which may potentially result in one or more images missing in a study | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| 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 |
| Aug 6, 2020 | Merge PACS | Measurements done on the Merge PACS generated MPR s may have incorrect measurements. | Class II | Merge Healthcare, Inc. |
| 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 |
| May 8, 2020 | Merge Healthcare Merge Application Server Software Release and Merge Healthca... | An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score c... | Class II | Merge Healthcare, Inc. |
| May 8, 2020 | The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images o... | GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referr... | Class II | Ge Healthcare |
| 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 |
| Feb 10, 2020 | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management | Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| 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 |
| Dec 23, 2019 | SIGNA Pioneer 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 |
| Dec 23, 2019 | SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is... | It was identified that due to a potential installation workflow issue, the MR system date could b... | Class II | GE Healthcare, LLC |
| Dec 16, 2019 | Centricity Universal Viewer 6.0, a device that displays medical images and da... | Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are inco... | Class II | GE Healthcare, LLC |
| Dec 3, 2019 | Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer | An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... | Class II | GE Healthcare, LLC |
| Dec 3, 2019 | Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer | An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... | Class II | GE Healthcare, LLC |
| Dec 3, 2019 | Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer | An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... | Class II | GE Healthcare, LLC |
| Dec 3, 2019 | Lunar iDXA bone densitometer | An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... | Class II | GE Healthcare, LLC |
| Nov 25, 2019 | Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended... | GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... | Class I | GE Healthcare, LLC |
| Nov 25, 2019 | Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended... | GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... | Class I | GE Healthcare, LLC |
| Nov 12, 2019 | CARESCAPE Central Station - Product Usage: The intended use is to provide cli... | When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... | Class II | GE Healthcare, LLC |
| Nov 12, 2019 | CIC Pro Clinical Information Center Central Station - Product Usage: The inte... | When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... | Class II | GE Healthcare, LLC |
| Nov 12, 2019 | ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is int... | When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... | Class II | GE Healthcare, LLC |
| Oct 11, 2019 | Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe Omn... | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | GE Healthcare, LLC |
| Oct 11, 2019 | Giraffe Incubator infant warmer | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | 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.