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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Jul 24, 2017 Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implan... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implant... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implanta... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implant... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillator... Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 625... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF

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.