Freeman Pancreatic Flexi-Stent label displays incorrect expiration date
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on their labels. The labeling error extends the shelf life beyond the intended timeframe.
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 medical device recall for an incorrect expiration date label. The error extends the shelf life beyond the intended date, creating a risk that expired devices could be used in clinical procedures. No injuries or illnesses have been reported. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent devices (Catalog Number 6584) because the product label displays an incorrect expiration date. This labeling error extends the shelf life of affected devices beyond the intended timeframe.
Devices with an extended shelf life could be used after their actual expiration date. The recall covers devices distributed between March 25, 2018, and September 28, 2020, with expiration dates between November 1, 2022, and September 1, 2025.
Affected devices were distributed worldwide in the United States, Canada, Austria, Belgium, Finland, and Norway. Specifically, devices with lot numbers ending in R, or kits containing at least one device with a lot number ending in R, are affected by this recall.
Healthcare facilities and practitioners should verify the expiration date of their Freeman Pancreatic Flexi-Stent devices and discontinue use if the device may exceed its actual shelf life.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6584
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- 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: M84965840 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.
See all 61 products in this recall →Related recalls
Same manufacturer · Hobbs Medical, Inc.
See all →- HighPosi-Stop Injection Needle Recalled Due to Manufacturing Debris Blockage
FDA (Devices) · 2024-11-27
- HighPosi-Stop Injection Needle Recall Due to Manufacturing Debris
FDA (Devices) · 2024-11-27
- HighPosi-Stop Injection Needles Recalled Due to Manufacturing Debris Blocking Injection Flow
FDA (Devices) · 2024-11-27
- HighPosi-Stop Injection Needles recalled for manufacturing debris blockage
FDA (Devices) · 2024-11-27
- HighInjection Needles Recalled for Manufacturing Debris Blocking Medication Flow
FDA (Devices) · 2024-11-27
Same hazard · mis labeling
See all →- ModerateWonton Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-09
- ModerateWonton Specialist Dumpling Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- ModerateAllies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets
FDA (Drugs) · 2026-09-09