The Recall Desk
HighFDA (Devices)·Z-0475-2025·Announced 2024-11-27

Posi-Stop 25-Gauge Injection Needles Recalled for Manufacturing Debris Blockage

Hobbs Medical is recalling Posi-Stop 25-Gauge injection needles because some units contain manufacturing debris that blocks the needle's inner diameter, preventing injection solutions from flowing properly.

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: FDA Class II medical device recall with no reported injuries or hospitalizations. This is a risk-of-harm product (injection needles) with potential for medication delivery failure, meeting the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Hobbs Medical, Inc. is recalling the Posi-Stop Injection Needle, 25 Gauge (Catalog Number 4722). Approximately 198 units with the following lot numbers are affected: H08-23-265, H09-23-113, H10-23-223, and H11-23-058.

The recalled needles contain manufacturing debris within the inner sheath that blocks the needle's inner diameter. This blockage prevents injection solutions from flowing through the needle tip as intended.

The affected units were distributed nationwide in Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, West Virginia, and Canada. The FDA has classified this as a Class II recall.

The recalled product

Product
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Injection Needle
Hazard
Affected units
198

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: 4722
  • UDI-DI: M84947220
  • Lot Numbers: H08-23-265
  • H09-23-113
  • H10-23-223
  • H11-23-058.

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 9 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Hobbs Medical, Inc.

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Same hazard · manufacturing debris

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