Hobbs Biliary Pigtail Stent Kits recalled due to incorrect expiration dates
Hobbs Medical is recalling certain Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual validity. Affected devices distributed between March 2018 and September 2020 may be used beyond their true expiration date.
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 FDA Class II recall involves a risk-of-harm product where no illnesses or injuries have been reported. Using an expired medical device implant could compromise sterility and performance. Per the rubric, risk-of-harm products without reported injury are scored High (3).
Plain-English summary
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (catalog number 6001) due to incorrect expiration dates displayed on device labels. The labeling error allows the shelf life to extend beyond the actual expiration date of the product.
Affected devices were distributed nationwide in the United States and internationally in Canada, Austria, Belgium, Finland, and Norway between March 25, 2018, and September 28, 2020. Devices with lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R" are affected. Specific implicated lot numbers include H01-19-234 and H01-19-230.
Use of an expired medical device may compromise its sterility and safety performance. Patients and healthcare providers who possess or have implanted these stent kits should verify lot numbers and expiration dates. Any affected devices should not be used and should be returned or disposed of according to facility protocols.
The recalled product
- Product
- Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Biliary Stent
- Hazard
- expiration-date-mislabeling
- device-failure-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: M84960010 Lot Numbers: H01-19-234 H01-19-230
Distribution
Distributed nationwide across the United States.
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