FDA Device recall Z-2113-2019
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEV…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEV… by Burlington Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2113-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-07 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Burlington Medical |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Serial Numbers: 382976 382964 385618 391130 391143 382858 381860 385617 381858 381854 387903 391141 442855…Serial Numbers: 382976 382964 385618 391130 391143 382858 381860 385617 381858 381854 387903 391141 442855 381789 387954 382861 391150 387944 387965 419791 385623 414166 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2113-2019%22
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