Burlington Medical, LLC: Medical Device Recall in 2019 - (Recall #: Z-2115-2019)

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:

Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M

Product Classification:

Class II

Date Initiated: June 7, 2019

Date Posted: August 7, 2019

Recall Number: Z-2115-2019

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: 7

Code Information:

Serial Numbers: 385688 387953 385694 385696 387781 384424 382874

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated