Burlington Medical, LLC: Burlington Medical, Caps.
Read the official notice at FDA (device) →
Get alerts for Burlington Medical
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Burlington Medical, LLC
- Product
- Burlington Medical, Caps.
- Reason / hazard
- Potential for attenuation degradation over time, decreasing the lifespan.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide 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.
- Recall initiated
- 2026-02-11
- 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: 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).
- Product quantity
- 961 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Newport News
- State
- VA
- Country
- United States
- Event id
- 98415
Free daily digest + "My products" watchlist