FDA Device recall Z-1760-2026
Burlington Medical, Caps
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of Burlington Medical, Caps 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-1760-2026 |
| 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, Caps.
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: R8CAP; UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP; UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP; UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD). |
|---|
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-1760-2026%22
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