The Recall Desk
HighFDA (Devices)·Z-0469-2025·Announced 2024-11-27

Posi-Stop 23-Gauge Injection Needles recalled for manufacturing debris blockage

Hobbs Medical recalls Posi-Stop Injection Needles because manufacturing debris in the needle can block injection solution flow.

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 is an FDA Class II medical device recall involving a confirmed manufacturing defect that prevents proper device function. While no injuries or illnesses have been reported, a malfunctioning injection needle poses a risk of harm in clinical settings.

Plain-English summary

Hobbs Medical, Inc. is recalling the Posi-Stop Injection Needle, 23 Gauge (Catalog Number 4702). The recall affects 45 units with lot numbers H08-23-263 and H01-24-114, distributed across multiple states in the US and Canada.

Investigations found that some units contain manufacturing debris inside the needle that blocks the lumen, preventing injection solutions from flowing properly. Affected needles may malfunction during clinical use.

Healthcare facilities and medical professionals with affected lot numbers should discontinue use immediately and contact Hobbs Medical for return or disposal instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Injection Needles
Hazard
  • manufacturing-debris
  • needle-blockage

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 (4)

  • Catalog Number: 4702
  • UDI-DI: M84947020
  • Lot Numbers: H08-23-263
  • H01-24-114.

Distribution

Distributed nationwide across the United States.

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