FDA Medical Device Recalls (openFDA)
Hobbs Medical, Inc.: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
- Recall number
- Z-0472-2025
- Recalling firm
- Hobbs Medical, Inc.
- Product
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
- Status
- Open, Classified
- Initiated
- 2024-10-04
- Posted
- 2024-11-15
- Terminated
- not on file
- Reason
- Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- Root cause
- Process change control
- Action
- On October 4, 2024 and October 8, 2024 consignees were sent URGENT MEDICAL DEVICE RECALL Actions requested on your part: 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 1-860-684-7574, 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. The following assistance is available: " For questions related to the issue or product replacement, please contact Hobbs Medical Customer Service. " For questions related to product return please contact Hobbs Medical Customer Service Return instructions are provided on the Acknowledgement Form. " For questions related to the Acknowledgement Form and its return, please contact Hobbs Customer Service at 1-800-344-6227. In addition to standard complaint notification to Hobbs Medical, any adverse events experienced with the use of this product and/or quality problems should also be reported to the FDA s MedWatch Program by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fischers Lane, Rockville, MD 20857; or on the MedWatch website at www.fda.gov/medwatch We apologize for any inconvenience this communication may cause. We know that you place high value in our products and we appreciate your cooperation in this matter. Hobbs Medical is committed to maintaining your confidence in the safety and quality of the products that Hobbs Medical supplies.
- Quantity
- 15 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
- Lot, serial or model codes
- Catalog Number: 4721; UDI-DI: M84947210; Lot Number: H11-23-057.
- 510(k) numbers
- ["K834403"]
- PMA numbers
- not on file
- Product code
- FBK
- 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