Burlington Medical recalls BAT (Breast, Axilla and Thyroid) Coverage devices made with Xenolite 800 material from Jan 2025 to Jan 2026 due to potential lifespan reduction from material degradation.
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical is recalling breast, axilla, and thyroid coverage devices made with Xenolite 800 material between January 2025 and January 2026. These devices may experience reduced lifespan over time due to material degradation, though they do not pose an immediate safety risk.
The devices contain Xenolite 800 attenuation material that may degrade over time, leading to a shorter operational lifespan. This degradation does not cause immediate injury or malfunction but could result in the device becoming less effective over time.
Owners of Burlington Medical BAT (Breast, Axilla and Thyroid) Coverage devices with serial numbers manufactured between January 2025 and January 2026 are affected. Patients using these devices for medical purposes may be at risk of reduced device lifespan.
Check if your device has a model number starting with BATB, BATH, or BATM and was manufactured with Xenolite 800 material from January 2025 to January 2026. The product codes listed in the recall notice include specific serial numbers and model variants.
Identify your device model number (BATB, BATH, or BATM) and verify the product code matches the listed serial numbers in the recall notice.
Reach out to Burlington Medical for guidance on whether your device is affected and potential next steps.
The recall is due to potential attenuation degradation over time in the Xenolite 800 material used in these devices, which may reduce their lifespan.
No, the recall does not require immediate discontinuation of use. The hazard is related to reduced lifespan, not immediate safety risks.
Check your device model number (BATB, BATH, or BATM) and verify the product code matches the specific serial numbers listed in the recall notice for devices manufactured between January 2025 and January 2026.
We’ve drafted a message you can send Burlington Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1758-2026 — Burlington Medical Burlington Medical Hello, I own a Burlington Medical that is covered by recall Z-1758-2026 from Burlington Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
