Browse Device Recalls
6 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 6 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 6 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 9, 2018 | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929... | There is a supplier quality issue with the terminal blocks which may cause the terminal block to ... | Class II | Cenorin, LLC |
| Jun 7, 2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) M... | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or b... | Class II | Cenorin, LLC |
| Jun 7, 2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) ... | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or b... | Class II | Cenorin, LLC |
| Jun 7, 2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) M... | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or b... | Class II | Cenorin, LLC |
| Apr 24, 2014 | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of t... | Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a... | Class II | Cenorin, LLC |
| Jan 24, 2013 | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Wa... | The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperatur... | Class II | Cenorin, 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.