The Recall Desk
HighFDA (Devices)·Z-2115-2019·Announced 2019-08-07

Burlington Medical Recalls Overlap Vests Due to Potential Inadequate Radiation Protection

Burlington Medical is recalling seven Overlap Vests because the protective material may provide inadequate protection against scatter radiation.

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: The recall involves a risk-of-harm product where the protective material may be inadequate, posing a theoretical risk of long-term health conditions like cancer, but no injuries or illnesses have been reported.

Plain-English summary

Burlington Medical, LLC is recalling seven units of the Overlap Vest, Single Item, Product Number FVest. The affected part numbers include REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, and SEFVEST*M. The specific serial numbers for the recalled units are 385688, 387953, 385694, 385696, 387781, 384424, and 382874.

The recall was initiated because the protective material used in the manufacture of these vests could potentially provide inadequate protection for the user. Using the products could expose the user to scatter radiation of varying degrees, depending on variables such as distance, shielding, position, time, and kV. Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

The products were distributed nationwide in the United States and to foreign countries including Korea and Thailand. Users should stop using the affected vests and contact Burlington Medical, LLC for further instructions.

The recalled product

Product
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
7

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 (1)

  • Serial Numbers: 385688 387953 385694 385696 387781 384424 382874

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 recalled by Burlington Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 24 products in this recall →

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