Burlington Medical recalled 29 Demi Half Aprons distributed worldwide after finding attenuation material may degrade over time. The degradation shortens the protective lifespan. Healthcare facilities should stop using the aprons immediately and follow the manufacturer’s recall instructions.
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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Demi Half Aprons are protective garments used in medical settings to shield staff or patients during radiologic procedures. They incorporate attenuation material to reduce radiation exposure and are chosen for durability and shield effectiveness.
Attenuation material degradation could shorten the apron’s protective lifespan, potentially reducing shielding during procedures.
This recall is not described as part of a broader industry pattern.
The recall could require facilities to replace affected aprons to maintain shielding integrity and protect staff and patients.
Recall notices and model/UDI information are published by the FDA and Burlington Medical. See the FDA enforcement page linked in this notice.
Not specified by the recall.
Retain the recall notice, product labels, model numbers, and any correspondence with the manufacturer and healthcare facilities.
Model numbers affected: R8DHALFR DHALF8-R8DHALFR-L DHALF8-R8DHALFR-M DHALF8-R8DHALFR-S DHALF8-R8DHALFR-XL DHALFSET8-R8DHALFR-SET Where sold: Worldwide distribution, including US nationwide and export to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay and Vietnam Sold since: Manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026 Price: Unknown
No injuries or incidents have been reported.
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