FDAFDA · Food and drugs·Recall number Z-0473-2025
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Published November 27, 2024 · Recall initiated: October 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hobbs Medical, Inc.
- Distributor
- 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
- Catalog Number: 4704; UDI-DI: M84947040; Lot Numbers: H10-23-106, H11-23-059.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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