Burlington Medical Recalls 129 Full Overlap Radiation Protection Vests and Kilts
Burlington Medical is recalling 129 two-piece radiation protection vests and kilts because the protective material may provide inadequate shielding against scatter radiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (radiation protection) where the hazard is theoretical (potential inadequate protection) and no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Burlington Medical, LLC is recalling 129 units of the 2 pc Full Overlap Vest & Kilt, Single Item (Product Number FVK). The affected products include specific part numbers such as REFVK*F, REFVK*M, and SEFVK*F. These items were distributed nationwide in the United States and to Korea and Thailand.
The recall was initiated because the protective material used in the manufacture of the products could potentially provide inadequate protection for the user. Use of these products could expose healthcare workers 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.
Healthcare workers and facilities that have received these products should stop using them immediately. The recall notice lists specific serial numbers for the affected units. Users should contact Burlington Medical, LLC for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
- Manufacturer
- Burlington Medical, LLC
- Affected units
- 129
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.
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