The Recall Desk
HighFDA (Devices)·Z-2111-2019·Announced 2019-08-07

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.

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 (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, UEF111XLM
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
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.

See all 24 products in this recall →

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