FDA DevicesClass II
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Published: April 8, 2026Recall ID: Z-1758-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Product Description & Identification
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
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: BATB; UDI-DI (Product Code): 00197513011941 (BATC18-R8BATB-2XF ), 00197513011941 (BATC18-R8BATB-3XF ), 00197513011941 (BATC8-R8BATB-LF ), 00197513011941 (BATC8-R8BATB-LM ), 00197513011941 (BATC8-R8BATB-MF ), 00197513011941 (BATC8-R8BATB-MM ), 00197513011941 (BATC8-R8BATB-PLUS ), 00197513011941 (BATC8-R8BATB-SF ), 00197513011941 (BATC8-R8BATB-XLF ), 00197513011941 (BATC8-R8BATB-XLM ), 00197513011941 (BATC8-R8BATB-XSF ). 2. Model Number: BATH; UDI-DI (Product Code): 00197513011934 (BATC18-R8BATH-2XF ), 00197513011934 (BATC18-R8BATH-2XM ), 00197513011934 (BATC18-R8BATH-3XF ), 00197513011934 (BATC18-R8BATH-3XM ), 00197513011934 (BATC8-R8BATH-LF ), 00197513011934 (BATC8-R8BATH-LM ), 00197513011934 (BATC8-R8BATH-MF ), 00197513011934 (BATC8-R8BATH-MM ), 00197513011934 (BATC8-R8BATH-PLUS ), 00197513011934 (BATC8-R8BATH-SF ), 00197513011934 (BATC8-R8B... [TRUNCATED] |
| Postal code | 23603-1137 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 1,489 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.