FDA DevicesClass II
Burlington Medical, Blockers.
Published: April 8, 2026Recall ID: Z-1764-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Product Description & Identification
Burlington Medical, Blockers.
Additional Source Details
| Field | Value |
|---|---|
| City | Newport News |
| State | VA |
| Event id | 98415 |
| Address 1 | 3 Elmhurst St |
| Address 2 | Suite 112 |
| Code info | All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8BLOCKER1; UDI-DI (Product Code): 00840331272895 (BLOCKER8-R8BLOCKER1). 2. Model Number: R8BLOCKER2; UDI-DI (Product Code): 00840331272901 (BLOCKER8-R8BLOCKER2). 3. Model Number: R8BLOCKER3; UDI-DI (Product Code): 00840331272918 (BLOCKER8-R8BLOCKER3). 4. Model Number: R8BLOCKER4; UDI-DI (Product Code): 00840331272932 (BLOCKER8-R8BLOCKER4). 5. Model Number: R8BLOCKER5; UDI-DI (Product Code): 00840331272949 (BLOCKER8-R8BLOCKER5). 6. Model Number: R8BLOCKER6; UDI-DI (Product Code): 00840331272956 (BLOCKER8-R8BLOCKER6). 7. Model Number: S8BLOCKER1; UDI-DI (Product Code): 00840331272963 (BLOCKER8-S8BLOCKER1). 8. Model Number: S8BLOCKER2; UDI-DI (Product Code): 00840331272970 (BLOCKER8-S8BLOCKER2). 9. Model Number: S8BLOCKER3; UDI-DI (Product Code): 00840331272987 (BLOCKER8-S8BLOCKER3). 10. Model Number: U8BLOCKER1; UDI-DI (Product... [TRUNCATED] |
| Postal code | 23603-1137 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 51 units |
| Reason for recall | Potential for attenuation degradation over time, decreasing the lifespan. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260211 |
| Initial firm notification | Letter |
| Center classification date | 20260402 |
Overview
- Recalling FirmBurlington Medical, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.