Burlington Medical Frontal Support Belt Apron Recalled for Inadequate Radiation Protection
Burlington Medical is recalling six Frontal 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 where the protective material may be inadequate, potentially exposing users to radiation with long-term health risks, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Burlington Medical, LLC is recalling six units of the Frontal Support Belt Apron, Product Number F-15. The affected part numbers are REF15*F, REF15*M, REF15B, and REF15XLM. The specific serial numbers for the recalled units are 418940, 444702, 387785, 442470, 443381, and 381937.
The recall was initiated because the protective material used in the manufacture of these 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.
The products were distributed nationwide in the United States and to Korea and Thailand. These 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 recalled product
- Product
- Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the…
- Manufacturer
- Burlington Medical, LLC
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 418940 444702 387785 442470 443381 381937
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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