RecallRadar

FDA Device recall Z-0556-2020

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690

On 2019-12-04 the FDA classified a Class II recall of Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690 by Boston Scientific, citing product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0556-2020
ClassificationClass II
Statusterminated
Initiated2019-10-21
Published2019-12-04
Last updated2026-09-13 11:55 UTC
CompanyBoston Scientific
DistributionUS

Product

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690

Reason

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

Identifiers

code_infoLot Numbers: 21568465 21724128 22072356 22250324 22480145 23902872

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-0556-2020%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.