RecallRadar

FDA Device recall Z-0296-2021

LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

On 2020-11-04 the FDA classified a Class II recall of LOM Disposable Surgical Gowns/Medical Gowns, Single-Use by Thread Counsel, citing medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0296-2021
ClassificationClass II
Statusongoing
Initiated2020-09-17
Published2020-11-04
Last updated2026-09-13 11:55 UTC
CompanyThread Counsel
DistributionNY

Product

LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

Reason

Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.

Identifiers

code_infoLots 1 -47

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0296-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.