The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2120-2019·Announced 2019-08-07

Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding

Burlington Medical is recalling two 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 where the protective function is potentially inadequate, posing a theoretical risk of long-term health conditions like cancer, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Burlington Medical, LLC is recalling two units of the 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron. The affected units have serial numbers 395561 and 395557 and part numbers SEB52*F and UEB52*M. These products were distributed nationwide in the United States and to Korea and Thailand.

The recall is being issued because the protective material used in the manufacture of the products could potentially provide inadequate protection for the user. Use of these aprons 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 products for fluoroscopic and radiographic procedures should stop using them immediately. The products are designed to protect against scatter (secondary) radiation by reducing the amount of radiation reaching the user, but the current recall indicates this function may be compromised.

The recalled product

Product
1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by…
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
2

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: 395561 395557

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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