Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Dates
Hobbs Medical recalled Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on labels that extend the shelf life, potentially allowing use beyond 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: FDA Class II medical device recall where incorrect expiration dating extends shelf life, creating a risk-of-harm situation if devices are used beyond their true expiration date.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent devices (Catalog Number 6566) due to incorrect expiration dates on device labels. The labeling error extends the shelf life, potentially allowing use of devices beyond their intended expiration period.
Affected devices were distributed in the United States from March 25, 2018, through September 28, 2020. Specifically, devices with lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R" are affected. The incorrect expiration dates on affected labels range from November 1, 2022, to September 1, 2025. The product was also distributed internationally to Canada, Austria, Belgium, Finland, and Norway.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6566
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 8
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: M84965660 Lot Numbers: H01-18-204R
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 →- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- HighHalyard DAVINCI TRUCUSTOM Foley Catheter Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02