Browse Device Recalls
14 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 14 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 14 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item nu... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: L... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline... | Within the Irish Market, a Field Safety Notice is being issued due to a select number of authoriz... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: ... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifel... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Jul 12, 2024 | RMU-2000 Automated Chest Compression Device | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay... | Class I | Defibtech, LLC |
| Feb 14, 2023 | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on ... | A component of a sub-assembly used in the affected AEDs had not undergone durability and reliabi... | Class II | Defibtech, LLC |
| Apr 27, 2020 | DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated Extern... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 27, 2020 | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 27, 2020 | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN ... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, 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.