Browse Device Recalls
25 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 25 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 25 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 8, 2021 | BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Produc... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 -... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Prod... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 -... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Produc... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Pr... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Prod... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Produ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Produ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usag... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usa... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usa... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Produ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usag... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usa... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Pr... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Pro... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usa... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
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.