Freeman Pancreatic Flexi-Stent recalled for incorrect expiration date
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels that extend perceived shelf life beyond actual device longevity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 labeling defect on a pancreatic stent—a critical medical device—that creates risk of device failure if used beyond actual shelf life. No illnesses or injuries have been reported, placing this at the maximum allowed for theoretical harm without reported incidents.
Plain-English summary
Freeman Pancreatic Flexi-Stent devices (Catalog Number 6582) manufactured by Hobbs Medical, Inc. are being recalled due to incorrect expiration dates displayed on product labels.
The affected devices were distributed in the United States and internationally (Canada, Austria, Belgium, Finland, and Norway) from March 25, 2018 through September 28, 2020. Affected devices have lot numbers ending in "R" and display expiration dates ranging from November 1, 2022 to September 1, 2025. The labels indicate shelf life longer than the actual safe use period of the device.
Consumers who have received these devices should verify their lot numbers and contact Hobbs Medical, Inc. for guidance. Using a medical stent beyond its actual shelf life may compromise device integrity and performance. If you have questions about a specific device or need assistance, contact the manufacturer immediately.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6582
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Stent
- Affected units
- 4
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: M84965820 Lot Numbers: H07-16-033R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 61 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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