Browse Device Recalls
368 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 368 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 368 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 16, 2012 | bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrumen... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrume... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrum... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instr... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrum... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB up... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, US... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument ... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument softw... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Aug 28, 2012 | PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durha... | The instrument may not dispense the specimen onto the pre-poured media resulting in a false negat... | Class II | Biomerieux 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.