FDA DevicesClass II
Burlington Medical, Thyroid Shield.
Published: April 8, 2026Recall ID: Z-1753-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Product Description & Identification
Burlington Medical, Thyroid Shield.
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: R8COPEH; UDI-DI (Product Code): 00840331299052 (COPE-R8COPEH-LG). 2. Model Number: R8TSBBB; UDI-DI (Product Code): 00840331260311 (THYROIDSHIELDO8-R8TSBBB-SM). 3. Model Number: R8TSBBN; UDI-DI: 00840331260328; Product Codes: THYROIDSHIELDO8-R8TSBBN-LG, THYROIDSHIELDO8-R8TSBBN-MD, THYROIDSHIELDO8-R8TSBBN-SM. 4. Model Number: R8TSBBR; UDI-DI (Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG), 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD), 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). 5. Model Number: R8TSBBT; UDI-DI (Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD), 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). 6. Model Number: R8TSBHB; UDI-DI (Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD), 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). 7. Model Number: R8TSBHN; UDI-DI (Product Code): 00840331260427 (THYROIDS... [TRUNCATED] |
| Postal code | 23603-1137 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 41,962 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.