FDA Enforcement
Class II
Ongoing
Burlington Medical, Demi Half Aprons.
Recall: Z-1763-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1763-2026
- Event ID
- 98415
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Burlington Medical, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- February 11, 2026
- Classification Date
- April 2, 2026
- Address
- 3 Elmhurst St, Suite 112, Newport News, VA, 23603-1137, United States
Description
Burlington Medical, Demi Half Aprons.
Reason
Potential for attenuation degradation over time, decreasing the lifespan.
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: R8DHALFR; UDI-DI (Product Code): 00197513001485 (DHALF8-R8DHALFR-L), 00197513001478 (DHALF8-R8DHALFR-M), 00197513001461 (DHALF8-R8DHALFR-S), 00197513001492 (DHALF8-R8DHALFR-XL), 00197513001607 (DHALFSET8-R8DHALFR-SET).
Distribution
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.
Quantity
29 units