Burlington Medical, LLC: Medical Device Recall in 2019 - (Recall #: Z-2111-2019)

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:

1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E, UEF111XLM, UEF111XXLM 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-2111-2019

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: 51

Code Information:

Serial Numbers: 379682 379535 423744 423745 387796 426462 419802 384492 377568 379681 379690 379698 386085 377724 382991 384347 385884 386083 381755 379715 385640 381868 426861 426802 426955 426895 426634 426809 426951 416567 426461 426789 426952 381869 443767 443802 377712 381865 377711 382966 381899 381866 382876 387805 382949 385982 423502 339345 423501 414165 414167

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated