Burlington Medical, LLC: Medical Device Recall in 2019 - (Recall #: Z-2118-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

Product Classification:

Class II

Date Initiated: June 7, 2019

Date Posted: August 7, 2019

Recall Number: Z-2118-2019

Event ID: 83144

Reason for Recall:

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 many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

Status: Terminated

Product Quantity: 37

Code Information:

Serial Numbers: 387197 384398 387814 418788 419871 387879 385725 385749 385732 387887 382947 419840 418873 423988 385738 387937 444696 418901 381799 419884 379705 386112 416433 415529 443261 418973 419967 419814 423980 419787 419892 391089 391128 385744 379537 417552 414129

Distribution Pattern:

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated