The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2128-2019·Announced 2019-08-07

Burlington Medical Recalls Radiation Protection Hoods Due to Inadequate Shielding

Burlington Medical is recalling three radiation protection hoods because the protective material may not adequately shield users from 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 (radiation shielding) where injury has not yet been reported, aligning with the High severity criteria for theoretical hazards.

Plain-English summary

Burlington Medical, LLC is recalling three units of radiation protection hoods (Part Numbers HOOD1 and HOOD2). The products were distributed nationwide in the United States and to Korea and Thailand. The specific serial numbers affected are 419558, 419557, and 414132.

The recall was initiated because the protective material used in the manufacture of the hoods could potentially provide inadequate protection for the user. Using these products may expose healthcare workers 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 source text does not specify instructions for consumers or healthcare facilities on how to handle the recalled units.

The recalled product

Product
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 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
3

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: 419558 419557 414132

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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