Browse Device Recalls
13 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 13 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 13 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 5, 2026 | Campy CVA Medium 100/PK, R01272 | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lo... | Class II | Remel, Inc |
| Nov 12, 2025 | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10... | Products may contain contamination, which may result in a darker or brown media color. | Class II | Remel, Inc |
| Jul 11, 2025 | Blood/EMB, Levine 100/PK, Product Number R02041 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Strep Selective II Agar, Product Number R01859 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Blood/MacConkey Biplate 100/PK, Product Number R02049 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| May 1, 2025 | Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/... | Product may have an off color affecting perfomance | Class II | Remel, Inc |
| Feb 13, 2025 | remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro dia... | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... | Class II | Remel, Inc |
| Feb 13, 2025 | remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnosti... | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... | Class II | Remel, Inc |
| Feb 12, 2025 | Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may hav... | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fir... | Class II | Remel, Inc |
| Sep 20, 2024 | remel BactiDrop Acridine Orange, REF 21502, 50 per package. | A color change of the solution within the dropper can occur from orange-yellow to light yellow re... | Class II | Remel, Inc |
| Aug 14, 2023 | remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B St... | On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during custome... | Class II | Remel, Inc |
| May 31, 2023 | Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Ha... | The test medium may not perform as intended. | Class II | Remel, 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.