Class II — Hobbs Medical, Inc.
| Recalling firm | Hobbs Medical Inc |
|---|---|
| Registered facility | HOBBS MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 |
| Quantity | 6 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. |
| Initiated | 2024-10-04 |
| Classified | 2024-11-15 |
| Recall number | Z-0470-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hobbs Medical, Inc. (Z-0470-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95577/
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