The Recall Desk
HighFDA (Devices)·Z-0044-2023·Announced 2022-10-19

Biliary Pigtail Stent Kits Recalled Due to Incorrect Expiration Date Labels

Hobbs Medical recalls Biliary Pigtail Stent Kits with labeling showing incorrect expiration dates that extend the shelf life. Affected kits were distributed to US and international customers from March 2018 to September 2020.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of a high-risk medical device with a labeling error that extends the perceived shelf life. No illnesses or injuries have been reported, but expired stents pose a risk of device failure during critical procedures, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (catalog number 6105) due to incorrect expiration dates displayed on device labels. The labeled expiration dates (November 1, 2022 to September 1, 2025) extend the actual shelf life of the affected devices.

When device labels show incorrect, extended expiration dates, healthcare providers may use stents that have exceeded their actual safe working life. Expired or degraded medical devices may not function as designed, potentially compromising safety during biliary procedures.

Affected kits were distributed worldwide from March 25, 2018 to September 28, 2020, including to US locations and the countries of Canada, Austria, Belgium, Finland, and Norway. Affected devices have lot numbers ending in "R" or are kits containing at least one device with a lot number ending in "R" (specific lot: H10-17-031R).

Healthcare facilities should immediately discontinue use of affected Biliary Pigtail Stent Kits and verify lot numbers against this recall notice. Contact Hobbs Medical, Inc. to arrange for device removal or replacement.

The recalled product

Product
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Biliary Stent
Hazard
  • expiration-date-error
  • shelf-life-mislabeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: M84961050 Lot Numbers: H10-17-031R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category