Medical device recalls Moderate risk

Hobbs Medical, Inc. recalls Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706

Recall date
October 4, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0470-2025
FDA classification
Class II
Brand / firm
Hobbs Medical, Inc.
Sold / distributed
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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706

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