Skip to content
Recall Observatory FDA recall evidence

Device product

Burlington Medical, Demi Half Aprons.

Z-1763-2026

February 11, 2026

Class II

Product summary

Firm
Burlington Medical, LLC
Event
Event 98415
Status
Ongoing
Classification
Class II
Quantity
29 units
Official record key
device-enforcement:Z-1763-2026

Official wording

Reason: Potential for attenuation degradation over time, decreasing the lifespan.

Code information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for attenuation degradation over time, decreasing the lifespan.