The Recall Desk
HighFDA (Devices)·Z-2127-2019·Announced 2019-08-07

Burlington Medical Recalls Radiation Protection Caps Due to Inadequate Shielding

Burlington Medical is recalling 49 radiation protection caps because the protective material may not adequately shield users from 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 is classified as FDA Class II and involves a risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Burlington Medical, LLC is recalling 49 units of radiation protection caps (Part Numbers CAP1 and CAP2). These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

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 units and contact Burlington Medical for instructions on return or replacement.

The recalled product

Product
Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: 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.
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
49

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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