The Recall Desk
HighFDA (Devices)·Z-0041-2023·Announced 2022-10-19

Hobbs Medical Recalls Biliary Stent Kits Due to Mislabeled Expiration Dates

Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits with incorrect expiration dates displayed on device labels. Affected devices distributed from March 2018 through September 2020 may be used beyond their validated shelf life.

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: Medical devices with mislabeled expiration dates pose a risk of harm through potential device degradation, compromised sterility, or loss of effectiveness when used beyond validated shelf life. This is an FDA Class II recall with no reported illnesses or injuries, 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 due to incorrect expiration dates displayed on device labels. The labeling error extends the indicated shelf life of the affected devices, potentially allowing them to be used beyond their validated safe use period.

Affected devices were distributed in the United States, Canada, Austria, Belgium, Finland, and Norway from March 25, 2018, through September 28, 2020. Lot numbers affected are those ending in 'R' or kits containing at least one device with a lot number ending in 'R.' The affected devices show expiration dates between November 1, 2022, and September 1, 2025.

Clinicians and patients should not use affected devices beyond the expiration date. If you have received any of these stents, verify the lot number and contact the manufacturer or your healthcare provider for guidance. The FDA has not received any reports of patient injury or device failure associated with this issue at this time.

The recalled product

Product
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Biliary Stent
Hazard
  • mis-labeling
  • sterility-risk

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: M84960270 Lot Numbers: H01-19-241

Distribution

Distributed nationwide across the United States.

Related recalls

Same category