FDA-Device2026-04-08Class IIPROCESSING DEFECT

Burlington Medical Demi Half Aprons recalled for material degradation reducing lifespan

OTHERNationwide distributionMedical devices

What this means

Burlington Medical Demi Half Aprons made with Xenolite 800 material between January 2025 and January 2026 may degrade over time, reducing how long they last. This affects 29 units sold worldwide. No injuries have been reported.

  • Check if your apron model matches R8DHALFR and was made between 01/16/2025–01/21/2026
  • Review the product code on your apron (look for DHALF8-R8DHALFR-L, -M, -S, -XL, or DHALFSET8-R8DHALFR-SET)
  • Contact Burlington Medical for guidance on replacement or repair options
The agency's original wording
Hazard

Potential for attenuation degradation over time, decreasing the lifespan.

Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
29 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Demi Half Aprons.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1763-2026

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