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 |
|---|---|---|---|---|
| Feb 18, 2022 | Signa 1.5T TwinSpeed Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | Class II | GE Healthcare, LLC |
| Jan 28, 2022 | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF... | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Contou... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with E... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vec... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthon... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infini... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T S... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSp... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Console" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector USB" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual USB" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Oct 15, 2021 | GE Centricity Universal Viewer Zero Footprint Client | There is a potential to display incomplete patient imaging study. | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | SIGNA Premier nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | Discovery MR750 3.0T nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | SIGNA Artist nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | SIGNA Voyager nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | Discovery MR750w 3.0T nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | SIGNA Architect nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | Class II | GE Healthcare, LLC |
| Aug 26, 2021 | 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... | 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.