Burlington Medical recalled 41,962 Thyroid Shield units worldwide after identifying attenuation degradation that could shorten the device’s lifespan. The attenuation material may degrade over time, reducing shielding effectiveness. Patients and healthcare providers should stop using the device immediately and follow the recall instructions in the manufacturer notice.
Potential for attenuation degradation over time, decreasing the lifespan.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Burlington Medical, LLC or your healthcare provider for instructions. Notification method: Letter
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The Burlington Medical Thyroid Shield is used to protect the thyroid during radiologic imaging. It is distributed globally to clinics and hospitals.
Over time, attenuation degradation could reduce shielding effectiveness, potentially increasing radiation exposure during procedures.
This recall is not described as part of a broader industry pattern.
41,962 units recalled with no reported injuries. Immediate stop-use is advised pending recall instructions.
Recall notice and detailed instructions are available via the FDA enforcement report and Burlington Medical communications.
Refund or replacement processing timelines are not specified in the notice.
Keep the recall letter, all model numbers, and any correspondence with Burlington Medical for records.
Model numbers: R8COPEH; R8TSBBB; R8TSBBN; R8TSBBR; R8TSBBT; R8TSBHB; R8TSBHN; R8TSBHR; R8TSBHT. Sold worldwide, including US nationwide, and distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam. Manufactured 2025-01-16 to 2026-01-21. Price: Unknown.
No injuries or incidents have been reported.
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