FDA Device recall Z-1758-2026
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage by Burlington Medical, citing potential for attenuation degradation over time, decreasing the lifespan.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1758-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-11 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Burlington Medical |
| Distribution | US |
Product
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Reason
Potential for attenuation degradation over time, decreasing the lifespan.
Identifiers
| code_info | All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1758-2026%22
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