FDA-Device2026-04-08Class IIPROCESSING DEFECT

Burlington Medical Blockers recalled for material degradation affecting device lifespan

OTHERNationwide distribution

Check your Burlington Medical Blockers serial number

Burlington Medical has recalled certain Blocker models because the Xenolite 800 material used in their construction may degrade over time, reducing how long the device will work properly. The recall affects units manufactured between January 16, 2025 and January 21, 2026. No injuries have been reported.

  • Check if your Blocker matches one of the affected model numbers (R8BLOCKER1-6, S8BLOCKER1-3, or U8BLOCKER1) and was made during the recall period
  • Contact Burlington Medical with your serial number and model for instructions on replacement or repair
  • Do not discard the device 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
51 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Blockers.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1764-2026

More Burlington Medical, LLC recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief