Burlington Medical, LLC: Burlington Medical, Demi Half Aprons.

Hazard

Potential for attenuation degradation over time, decreasing the lifespan.

Details from the source

Reason for recall: Potential for attenuation degradation over time, decreasing the lifespan. 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 Lot/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).

UPC codes

00197513001485, 00197513001478, 00197513001461, 00197513001492, 00197513001607

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.