RecallRadar

FDA Device recall Z-0779-2021

Resect

On 2021-01-13 the FDA classified a Class II recall of Resect by Medline Industries, citing the cylindrical sponge component is not x-ray detectable.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0779-2021
ClassificationClass II
Statusterminated
Initiated2020-11-13
Published2021-01-13
Last updated2026-09-13 11:56 UTC
CompanyMedline Industries
Distributionn/a

Product

Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Reason

The cylindrical sponge component is not x-ray detectable.

Identifiers

code_infoLot 20GBA365 (Expiration 11/30/2024), 20HBM367 (Expiration 11/30/2024), 20IBC934 (Expiration 11/30/2024)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0779-2021%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.