Browse Device Recalls
1,006 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,006 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 1,006 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2018 | B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable ... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 11, 2018 | B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 11, 2018 | PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE ... | Patient monitors may restart due to network overload caused by network configuration. | Class II | GE Healthcare, LLC |
| Sep 10, 2018 | DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision ... | Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion ... | Class II | GE Healthcare Biosciences |
| Sep 4, 2018 | GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CA... | When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... | Class II | GE Healthcare Finland Oy |
| Sep 4, 2018 | GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARE... | When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... | Class II | GE Healthcare Finland Oy |
| Aug 31, 2018 | Solar 8000i Patient Monitoring System is used to monitor physiologic paramet... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Dash 4000 Patient Monitoring System is used to monitor physiologic parameter ... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Dash 3000 Patient Monitoring System is used to monitor physiologic parameter ... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Solar 8000M Patient Monitoring System is used to monitor physiologic paramet... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Solar 9500 Information Monitoring System is used to monitor physiologic para... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 31, 2018 | Dash 5000 Patient Monitoring System is used to monitor physiologic parameter ... | The patient monitors may simultaneously restart as designed if all are connected to the same netw... | Class II | GE Healthcare, LLC |
| Aug 30, 2018 | Centricity Universal Viewer with Cross Enterprise Display This impacts produc... | Remote comparison studies displayed may be associated with the wrong patient, without a caution i... | Class II | GE Healthcare, LLC |
| Jul 12, 2018 | Revolution CT systems with the SmartStep Option The system is intended for... | On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on imag... | Class II | GE Healthcare, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the foll... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 12.x, sold under the following pr... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 11.x, sold under the following pr... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| May 25, 2018 | GE Healthcare CARESCAPE Monitor B650 | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overlo... | Class II | GE Healthcare Finland Oy |
| May 24, 2018 | Discovery NM/CT 670 ES, model 5376204-70-57 | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
| May 24, 2018 | CT Goldseal BrightSpeed 16 PWR TIO 2 YR | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery RT labeled as: a. MID BJG; b. HVY BJG | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery NM/CT 670 Pro, model 5376204-70-54 | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Revolution CT 160 1.5D STD WAUK | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Optima CT 540 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Optima CT 520 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, l... | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery MI Digital Ready | DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be ... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG ... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | CT Goldseal Optima CT 600 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| Apr 27, 2018 | GE Healthcare Optima CT540. The systems are intended for head, whole body, c... | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... | Class II | GE Healthcare Japan Corporation |
| Apr 27, 2018 | GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The ... | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... | Class II | GE Healthcare Japan Corporation |
| Apr 27, 2018 | GE Healthcare Optima CT660. Sold under the following product names: BEI... | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... | Class II | GE Healthcare Japan Corporation |
| Apr 27, 2018 | GE Healthcare Optima CT660. The systems are intended for head, whole body, c... | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC... | Class II | GE Healthcare Japan Corporation |
| Mar 16, 2018 | GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, ... | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 16, 2018 | GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model... | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 16, 2018 | GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU... | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 12, 2018 | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological mo... | Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monit... | Class II | McKesson Israel Ltd. |
| Feb 23, 2018 | GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 204958... | A database handling error could occur during the image acquisition process affecting the complete... | Class II | GE Healthcare |
| Jan 25, 2018 | Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW wit... | Potential that one or more image series may be missing from an exam without a user warning disp... | Class II | GE Healthcare |
| Jan 25, 2018 | Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricit... | Potential that one or more image series may be missing from an exam without a user warning disp... | Class II | GE Healthcare |
| Jan 11, 2018 | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th... | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (... | Class II | GE Medical Systems Information Technologies, Inc. |
| Dec 15, 2017 | Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Pro... | if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected... | Class II | GE Healthcare, LLC |
| Dec 15, 2017 | Uterine Electromyographic Monitor -Monica IF24 Interface System Product Us... | if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected ... | Class II | GE Healthcare, LLC |
| Oct 30, 2017 | VariCam | A potential hazardous situation may occur if the collimator locking handle is not properly placed... | Class II | GE Healthcare, LLC |
| Oct 30, 2017 | Discover VH/Millennium VG Nuclear Medicine Imaging System | A potential hazardous situation may occur if the collimator locking handle is not properly placed... | Class II | GE Healthcare, LLC |
| Oct 4, 2017 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered deliv... | Non-Conforming devices were shipped from the service center without proper evaluation and therefo... | Class II | GE Healthcare, LLC |
| Oct 4, 2017 | DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used... | Non-Conforming devices were shipped from the service center without proper evaluation and therefo... | Class II | GE Healthcare, LLC |
| Aug 14, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
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.