The Recall Desk
HighFDA (Devices)·Z-0471-2025·Announced 2024-11-27

Injection Needles Recalled for Manufacturing Debris Blocking Medication Flow

Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris inside the needle shaft that blocks medication flow. The affected lot was distributed across multiple US 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: FDA Class II recall with no reported illnesses or injuries. The manufacturing debris blockage prevents proper medication delivery through the needle, representing a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles, 23 Gauge (Catalog Number: 4716, Lot H01-24-076) due to manufacturing debris found in some units. The inner sheath of affected needles contains debris that blocks the inner diameter of the needle, preventing injection solutions from flowing properly through the needle tip.

The recalled lot containing five units was distributed nationwide in Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, West Virginia, and Canada.

Healthcare providers and patients who may have needles from this lot should stop using them immediately. Anyone who has questions or has experienced problems with these needles should contact Hobbs Medical, Inc. or report the incident to the FDA.

The recalled product

Product
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Injection Needle
Hazard
Affected units
5

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 (3)

  • Catalog Number: 4716
  • UDI-DI: M84947160
  • Lot Number: H01-24-076.

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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