The Recall Desk
HighFDA (Devices)·Z-1753-2026·Announced 2026-04-08

Burlington Medical thyroid shields may lose radiation attenuation over time

Burlington Medical is recalling thyroid shields over the potential for attenuation degradation over time, which decreases the product's usable lifespan. 41,962 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of protective equipment whose performance may degrade, creating a risk of harm; no injuries are reported in the source.

Plain-English summary

Burlington Medical is recalling its Thyroid Shield radiation protection garment. The action covers 41,962 units.

The firm cites the potential for attenuation degradation over time, decreasing the lifespan of the shield. A thyroid shield is worn to attenuate scattered radiation during imaging and interventional procedures, so reduced attenuation lowers the protection it provides to the wearer. The FDA classified the action as Class II.

The shields were distributed worldwide, including nationwide in the United States and to international markets. They are supplied to healthcare facilities rather than sold to consumers.

Facilities holding affected thyroid shields should follow the instructions issued by Burlington Medical and contact the firm with questions about testing or replacement.

The recalled product

Product
Burlington Medical, Thyroid Shield.
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation protection garment
Hazard
  • radiation-protection
  • attenuation-degradation
  • class-ii
  • protective-equipment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 00840331260328
  • Product Codes: THYROIDSHIELDO8-R8TSBBN-LG
  • THYROIDSHIELDO8-R8TSBBN-MD
  • THYROIDSHIELDO8-R8TSBBN-SM. 4. Model Number: R8TSBBR
  • UDI-DI (Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG)
  • 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD)
  • 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). 5. Model Number: R8TSBBT
  • UDI-DI (Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD)
  • 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). 6. Model Number: R8TSBHB
  • UDI-DI (Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD)
  • 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). 7. Model Number: R8TSBHN
  • UDI-DI (Product Code): 00840331260427 (THYROIDSHIELDO8-R8TSBHN-MD )
  • 00840331260434 (THYROIDSHIELDO8-R8TSBHN-SM ). 8. Model Number: R8TSBHR
  • UDI-DI (Product Code): 00840331260465 (THYROIDSHIELDO8-R8TSBHR-SM )
  • 00840331260458 (THYROIDSHIELDO8-R8TSBHR-MD )
  • 00840331260441 (THYROIDSHIELDO8-R8TSBHR-LG ). 9. Model Number: R8TSBHT
  • UDI-DI (Product Code): 00840331260489 (THYROIDSHIELDO8-R8TSBHT-MD )
  • 00840331260496 (THYROIDSHIELDO8-R8TSBHT-SM ). 10. Model Number: R8TSBMB
  • UDI-DI (Product Code): 00840331295979 (THYROIDSHIELDOM8-R8TSBMB-MD )
  • 00840331295986 (THYROIDSHIELDOM8-R8TSBMB-SM ). 11. Model Number: R8TSBMN

Distribution

Distributed nationwide across the United States.

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