Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 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 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| Aug 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in ... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| Aug 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use i... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| Dec 20, 2024 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use i... | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... | Class I | Max Mobility LLC |
| Dec 20, 2024 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in... | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... | Class I | Max Mobility LLC |
| May 10, 2023 | PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Devic... | When multiple processes are running on the watch's Central Processing Unit (CPU), the application... | Class II | Permobil |
| May 10, 2023 | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Devic... | When multiple processes are running on the watch's Central Processing Unit (CPU), the application... | Class II | Permobil |
| Sep 24, 2021 | Permobil TiLite, Models: Aero Z, and ZRA | Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor v... | Class II | TiSport, Llc |
| Aug 15, 2018 | Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C... | This correction decision has been made because of a potential failure of one or both backrest bar... | Class II | Permobil, Ab |
| Sep 1, 2017 | Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS I... | There is a potential failure of the top plate assembly, which is the component that connects the ... | Class II | Permobil, Ab |
| Sep 1, 2017 | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 | There is a potential failure of the top plate assembly, which is the component that connects the ... | Class II | Permobil, Ab |
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.