Burlington Medical Recalls Frontal Apron Velcro Closures Due to Radiation Protection Concerns
Burlington Medical is recalling 104 Frontal Apron Velcro Closures because the protective material may provide inadequate protection 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 ('could potentially provide inadequate protection') and no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Burlington Medical, LLC is recalling 104 units of Frontal Apron Velcro Closure, Product Number F-17. The affected products include various part numbers such as REF17A, REF17B, and UEF17A. These products 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 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 are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user. The source text does not specify instructions for consumers or healthcare workers on how to handle the recalled items.
The recalled product
- Product
- Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, UEF17XXLM Product Usage: Products are designed to protect healthcare…
- Manufacturer
- Burlington Medical, LLC
- Affected units
- 104
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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