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 |
|---|---|---|---|---|
| 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 |
| Oct 11, 2019 | Giraffe OmniBed infant warmer | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | GE Healthcare, LLC |
| Oct 11, 2019 | Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCOVX | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOE | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOVE | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | Airway Gas Option N-CAiO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOV | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 16, 2019 | CardioLab/ComboLab Recording Systems | Potential for failure of the patient leakage current test. There is a potential that if another d... | Class II | GE Healthcare, LLC |
| Sep 3, 2019 | Achilles Insight Bone Sonometer | Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow... | Class II | GE Healthcare, LLC |
| Sep 3, 2019 | Achilles Express Bone Sonometer | Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow... | Class II | GE Healthcare, LLC |
| Aug 30, 2019 | ApexPro Telemetry Server System. Also identified as Modification To: ApexPro... | May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Informa... | Class II | GE Healthcare, LLC |
| Aug 9, 2019 | Proteus XR/a (SlOK : K993090) | Intermittently not receiving an audible exposure indication upon completion of an exposure on the... | Class II | GE Healthcare, LLC |
| Jul 26, 2019 | Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated a... | Fasteners potentially torqued to a value less than the specified value and can potentially cause ... | Class II | GE Healthcare, LLC |
| Jul 19, 2019 | Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3.... | Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... | Class II | GE Healthcare, LLC |
| Jul 19, 2019 | Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-91... | Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... | Class II | GE Healthcare, LLC |
| Jul 19, 2019 | Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023... | Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... | Class II | GE Healthcare, LLC |
| Jul 19, 2019 | Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-... | Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... | Class II | GE Healthcare, LLC |
| Jul 2, 2019 | Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish R... | Potential for a transducer mis-alignment in certain transvaginal probes. | Class II | GE Healthcare, LLC |
| Jul 2, 2019 | Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D | Potential for a transducer mis-alignment in certain transvaginal probes. | Class II | GE Healthcare, LLC |
| Jun 28, 2019 | MAC VU360, Model Number 2030360-001, Electrocardiograph | Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit ... | Class II | GE Healthcare, LLC |
| May 22, 2019 | GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 ... | There is a potential that one or more image series (i.e., all images within an image set) may b... | Class II | GE Healthcare, LLC |
| May 21, 2019 | LVivo EF app on Vscan Extend. Sold under the following product names: a... | Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo E... | Class II | GE Healthcare, LLC |
| May 17, 2019 | Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255... | There is a potential that one or more images or image series may be missing from exams without a ... | Class II | GE Healthcare, LLC |
| May 17, 2019 | Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-00... | There is a potential that one or more images or image series may be missing from exams without a ... | Class II | GE Healthcare, LLC |
| May 16, 2019 | Centricity PACS Foundation Centricity PACS software product is intended fo... | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... | Class II | GE Healthcare, LLC |
| May 16, 2019 | GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory ... | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | Class II | GE Healthcare, LLC |
| May 16, 2019 | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital... | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | Class II | GE Healthcare, LLC |
| May 16, 2019 | Centricity Universal Viewer 6.0 Is a device that displays medical images a... | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... | Class II | GE Healthcare, LLC |
| May 10, 2019 | ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Replacement ECG leadwires with snap ends REF/Catalog Number Description 210... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cab... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Replacement leadwires with grabber ends: REF/Catalog Number Description 210... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 EC... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| Mar 29, 2019 | Precision 500D The Precision 500D R&F X-ray System is intended to be used... | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... | 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.