The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2126-2019·Announced 2019-08-07

Burlington Medical Recalls Half Aprons Due to Potential Radiation Protection Deficiency

Burlington Medical is recalling two half aprons because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.

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 protection) where injury has not yet been reported, and the hazard involves potential long-term exposure to radiation, fitting the 'High' severity criteria.

Plain-English summary

Burlington Medical, LLC is recalling two units of Half Aprons (Part Numbers REHALF*, REHALF3) with serial numbers 382955 and 418939. The recall was initiated because the protective material used in the manufacture of these products could potentially provide inadequate protection for the user.

These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures. The agency notes that 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. Healthcare workers and facilities that possess these specific serial numbers should stop using the products and contact the recalling firm for instructions.

The recalled product

Product
Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 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…
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
2

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: 382955 418939

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 →

Similar recalls