The Recall Desk
HighFDA (Devices)·Z-2110-2019·Announced 2019-08-07

Burlington Medical Recalls Frontal Quick Drop OR Aprons Due to Radiation Risk

Burlington Medical is recalling 23 Frontal Quick Drop OR 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 where the protective material may fail, potentially leading to 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 23 units of the Frontal Quick Drop OR Apron, Product Number 601. The affected units include specific part numbers such as ECRE601A, ECRE601B, and RE601C. These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures.

The recall was initiated because the protective material used in the manufacture of these aprons could potentially provide inadequate protection for the user. Using these products may 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. Healthcare workers and facilities should stop using the affected aprons immediately and contact Burlington Medical for instructions on how to return or replace the products.

The recalled product

Product
Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic an
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
23

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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