The Recall Desk
HighFDA (Devices)·Z-0468-2025·Announced 2024-11-27

Posi-Stop Injection Needles Recalled for Manufacturing Debris Blocking Flow

Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves a functional defect (manufacturing debris blocking proper needle function) with no reported illnesses or injuries. It qualifies as a risk-of-harm product where injury has not yet been reported, consistent with High severity criteria.

Plain-English summary

Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles, 23 Gauge (Catalog Number 4720) due to a manufacturing defect. This is a Class II recall by the U.S. Food and Drug Administration.

The affected lot numbers are H07-23-103, H07-23-104, H08-23-020, and H09-23-111. Investigations found that some units contained manufacturing debris within the inner sheath of the needle. This debris blocks the needle's inner diameter, preventing injection solutions from flowing through the needle tip as intended.

The recalled needles were distributed to healthcare facilities across multiple U.S. states (Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, and West Virginia) and Canada. In total, 70 units were affected.

Healthcare providers should not use these needles. Affected units should be discontinued from use and returned to the manufacturer or disposed of in accordance with local medical waste disposal regulations.

The recalled product

Product
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Injection Needle
Hazard
  • injection-failure
  • manufacturing-debris

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Catalog Number: 4720
  • UDI-DI: M84947200
  • Lot Numbers: H07-23-103
  • H07-23-104
  • H08-23-020
  • H09-23-111.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category