Burlington Medical recall (Burlington Medical, LLC)
Medical deviceClass IIOngoing
Summary: Burlington Medical, LLC is recalling Burlington Medical, Caps.. Reason: Potential for attenuation degradation over time, decreasing the lifespan.
What is being recalled
Burlington Medical, Caps.
Why
Potential for attenuation degradation over time, decreasing the lifespan.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
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).
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1760-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 11, 2026 |
| Reported | April 8, 2026 |
| Company | Burlington Medical, LLC |
| Company location | Newport News, VA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 961 units |
More recalls from Burlington Medical, LLC · all medical device recalls · recalls from February 2026