Burlington Medical Recalls Full Wrap Support Belt Aprons Due to Radiation Risk
Burlington Medical is recalling 51 Full Wrap Support Belt Aprons 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 exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Burlington Medical, LLC is recalling 51 units of the 1 pc Full Wrap Support Belt Apron, Product Number F111. The recall covers specific part numbers and serial numbers listed in the agency documentation. 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 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.
Healthcare workers who use these aprons to protect against scatter radiation during fluoroscopic and radiographic procedures are affected. Consumers should stop using the affected products and contact Burlington Medical for instructions on return or replacement.
The recalled product
- Product
- 1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E…
- Manufacturer
- Burlington Medical, LLC
- Hazard
- Affected units
- 51
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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