Burlington Medical, LLC: Medical Device Recall in 2019 - (Recall #: Z-2113-2019)

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:

Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM 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-2113-2019

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: 22

Code Information:

Serial Numbers: 382976 382964 385618 391130 391143 382858 381860 385617 381858 381854 387903 391141 442855 381789 387954 382861 391150 387944 387965 419791 385623 414166

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated