Recall Z-0470-2025— Hobbs Medical, Inc.

Name: FDA recall Z-0470-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-04

Class II · Ongoing

Class II FDA medical device recall by Hobbs Medical, Inc., initiated 2024-10-04. It names one FDA 510(k) clearance: K834403. Product: Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706. 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..

Recalling firm: Hobbs Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-10-04
Firm location: Stafford Springs, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K834403 — INJECTION NEEDLEBobbs Medical, Inc.·cleared 1984-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.