Hobbs Biliary Pigtail Stent Kit Label Bears Incorrect Expiration Date
Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual product expiration, potentially resulting in use of expired devices.
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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard involves the potential for device malfunction due to use of expired medical devices, which meets the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (Catalog Number 6028, UDI-DI: M84960280) due to incorrect expiration dates displayed on device labels. The label expiration date extends beyond the actual shelf life of the product.
The affected devices were distributed in the United States and internationally (Canada, Austria, Belgium, Finland, Norway) from March 25, 2018 to September 28, 2020. Affected lots have lot numbers ending in 'R' or are kits containing at least one device with a lot number ending in 'R'. The incorrect label expiration dates range from November 1, 2022 to September 1, 2025.
If you have one of these devices, contact Hobbs Medical, Inc. for instructions on returns or replacements. Healthcare facilities should immediately check their inventory for affected lots and remove them from use.
The recalled product
- Product
- Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Biliary Stent
- Hazard
- incorrect-labeling
- device-malfunction
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: M84960280 Lot Numbers: H02-19-021
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- HighMedline Industries Polycarbonate Syringes Convenience Kits Design Change Recall
FDA (Devices) · 2026-07-01
- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burr recalled for potential breakage risk
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01