The Recall Desk
HighFDA (Devices)·Z-2118-2019·Announced 2019-08-07

Burlington Medical Recalls Radiation Protection Kilts Due to Inadequate Shielding

Burlington Medical is recalling 37 radiation protection kilts because the protective material may provide inadequate shielding 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 be inadequate, posing a theoretical risk of long-term health conditions like cancer or infertility, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Burlington Medical, LLC is recalling 37 single-item radiation protection kilts. The 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 recall involves specific part numbers including ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, and SEKILT*M.

The recall is being conducted because the protective material used in the manufacture of the products could potentially provide inadequate protection for the product 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 foreign countries including Korea and Thailand. Healthcare workers and facilities should stop using the affected kilts and contact Burlington Medical for further instructions.

The recalled product

Product
Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while p
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
37

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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