FDA Medical devices recall ·
Posi-Stop Injection Needle, 23 Gauge recall
- Recall number
- Z-0472-2025
- Date
- (initiated October 4, 2024)
- Company / brand
- Hobbs Medical, Inc.
8 Spring St, Stafford Springs, CT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 4721; UDI-DI: M84947210; Lot Number: H11-23-057.
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.
States: Connecticut Georgia Indiana Michigan Minnesota Mississippi New Hampshire New Jersey New York Ohio Tennessee Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0472-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.