Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding
Burlington Medical is recalling 48 radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to 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 exposure) where injury has not yet been reported, fitting the 'High' severity criteria for potential long-term health risks without confirmed immediate injury.
Plain-English summary
Burlington Medical, LLC is recalling 48 units of Front/Back Aprons with Stretch Velcro Closure (Product Number EURO). The recall involves specific part numbers including ECSEEUROA, ECSEEUROB, and others, with serial numbers ranging from 377104 to 443366. 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 aprons could potentially provide inadequate protection for the user. The 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 aprons should stop using them immediately. The products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures. Users should contact Burlington Medical, LLC for further instructions on returning or replacing the affected units.
The recalled product
- Product
- Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F Product Usage: Products are designed to protect healthcare workers against scatter…
- Manufacturer
- Burlington Medical, LLC
- Hazard
- Affected units
- 48
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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