Browse Device Recalls
168 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 168 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 168 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2016 | LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner Syste... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Dec 23, 2015 | GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System ... | Potential safety latch mechanism failure. The safety latch, within the column that supports the ... | Class II | GE Medical Systems, LLC |
| Dec 23, 2015 | GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Des... | Potential safety latch mechanism failure. The safety latch, within the column that supports the ... | Class II | GE Medical Systems, LLC |
| Dec 23, 2015 | GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System ... | Potential safety latch mechanism failure. The safety latch, within the column that supports the ... | Class II | GE Medical Systems, LLC |
| Dec 18, 2015 | Mavig Monitor Suspension System, Model GD60, contained in the following Fluor... | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm wi... | Class II | GE Medical Systems, LLC |
| Dec 15, 2015 | GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avanc... | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... | Class II | GE Medical Systems, LLC |
| Dec 15, 2015 | Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ... | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... | Class II | GE Medical Systems, LLC |
| Dec 15, 2015 | GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia ... | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... | Class II | GE Medical Systems, LLC |
| Dec 15, 2015 | GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. ... | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... | Class II | GE Medical Systems, LLC |
| Dec 15, 2015 | GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda... | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... | Class II | GE Medical Systems, LLC |
| Dec 15, 2015 | GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda ... | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... | Class II | GE Medical Systems, LLC |
| Dec 7, 2015 | GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Us... | Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious ... | Class II | GE Medical Systems, LLC |
| Dec 7, 2015 | GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. | GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex ... | Class II | GE Medical Systems, LLC |
| Nov 13, 2015 | GE Healthcare Optima CL323i Product Usage: The angiographic X-ray system... | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... | Class II | GE Medical Systems, LLC |
| Nov 13, 2015 | GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray syste... | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... | Class II | GE Medical Systems, LLC |
| Oct 23, 2015 | GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte... | GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo... | Class II | GE Medical Systems, LLC |
| Sep 23, 2015 | MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UP... | GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Op... | Class II | GE Medical Systems, 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.