Browse Device Recalls
12 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 12 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 12 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 2, 2018 | T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercis... | A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 202618... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE LOGIQ 9 ultrasound system Product Usage: The device is intended for ... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound s... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is ... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E95 ultrasound system Product The device is intended for use by a... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for u... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultras... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Mar 22, 2018 | GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose... | The system side of the power cord may break and expose the electrical conductors leading to the r... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| 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... |
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.