FDA-Device2026-04-08Class IIPROCESSING DEFECT

Burlington Medical Kilt Blockers recalled for attenuation material degradation

OTHERNationwide distribution

Check your Burlington Medical Kilt Blockers

Burlington Medical Kilt Blockers with Xenolite 800 attenuation material made between January 2025 and January 2026 may degrade over time, reducing how long they work effectively. This affects 94 units across multiple model sizes distributed worldwide.

  • Check if your Kilt Blocker model number starts with R8, S8, or U8 and was made between 01/16/2025–01/21/2026
  • Contact Burlington Medical for instructions on replacement or repair
  • Do not discard the product until you receive guidance 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
94 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Kilt Blockers.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1765-2026

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