FDA Medical Device Recalls (openFDA)
Hobbs Medical, Inc.: Freeman Pancreatic Flexi-Stent Catalog Number: 6568
- Recall number
- Z-0063-2023
- Recalling firm
- Hobbs Medical, Inc.
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6568
- Status
- Open, Classified
- Initiated
- 2022-07-29
- Posted
- 2022-10-07
- Terminated
- not on file
- Reason
- Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- Root cause
- Process control
- Action
- Hobbs Medical issued URGENT RECALL letter via Certified Mail with return receipt requested on 7/29/22. Letter states reason for recall, health risk and action to take: 1. Read the Description of the problem section. 2. Immediately identify and set aside all product listed herein in a manner that ensures the affected product will not be used and will be returned to Hobbs Medical. 3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs Medical Customer Service, return via Fax at 860-684-7574, or email to CustomerService@HobbsMedical.com. 4. Pass on this notice to anyone in your facility that needs to be informed according to your internal notification procedures. 5. If any product listed below has been forwarded to another facility, contact that facility to arrange return. 6. Maintain awareness of this notice until all product listed above has been returned to Hobbs Medical. For questions related to the issue, the Acknowledgement form, and product replacement, please contact Hobbs Medical Customer Service at: 1-800-344-6227 CustomerService@hobbsmedical.com Return instructions are provided on the Acknowledgement Form
- Quantity
- 6 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
- Lot, serial or model codes
- UDI-DI: M84965680 Lot Numbers: H12-17-203R
- 510(k) numbers
- ["K834351"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1220592
- Firm city
- Stafford Springs
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28