RecallRadar

FDA Device recall Z-0040-2023

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024

On 2022-10-19 the FDA classified a Class II recall of Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024 by Hobbs Medical, citing device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0040-2023
ClassificationClass II
Statusongoing
Initiated2022-07-29
Published2022-10-19
Last updated2026-09-13 11:56 UTC
CompanyHobbs Medical
DistributionUS

Product

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024

Reason

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Identifiers

code_infoUDI-DI: M84960240 Lot Numbers: H02-19-023 H11-18-188

Status history

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

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0040-2023%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.