The Recall Desk
HighFDA (Devices)·Z-2123-2019·Announced 2019-08-07

Burlington Medical Recalls Radiation Protection Sleeves Due to Inadequate Shielding

Burlington Medical is recalling 39 radiation protection sleeves because the 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 shielding) where the hazard is theoretical (potential inadequate protection) and no injuries or illnesses have been reported, fitting the High severity criteria.

Plain-English summary

Burlington Medical, LLC is recalling 39 units of radiation protection sleeves. The affected products include part numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, and UESL. These sleeves 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 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.

The products were distributed nationwide in the United States and to Korea and Thailand. The recall is classified as Class II by the FDA. Healthcare facilities and users should stop using the affected sleeves and contact Burlington Medical for instructions on return or replacement.

The recalled product

Product
Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the am
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
39

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 →

Related recalls

Same manufacturer · Burlington Medical, LLC

See all →

Same hazard · radiation exposure

See all →