FDA-Device2026-04-08Class IIPROCESSING DEFECT

Burlington Medical Kilt recalled for attenuation material degradation over time

OTHERNationwide distribution

Check your Burlington Medical Kilt model

Burlington Medical is recalling certain Kilt models because the Xenolite 800 attenuation material used in them may break down over time, reducing how long the product lasts. The recall affects units made between January 16, 2025 and January 21, 2026.

  • Check if your Kilt matches one of the recalled model numbers (C8K303, R8K303, R8KILT, or R8S302)
  • Look at your product's serial number and manufacturing date
  • Contact Burlington Medical for instructions on repair or replacement
  • Do not discard the product until you hear from the manufacturer
Hazard

Potential for attenuation degradation over time, decreasing the lifespan.

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
15,216 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Kilt

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1755-2026

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