The Recall Desk
HighFDA (Devices)·Z-0025-2023·Announced 2022-10-19

Hobbs Posi-Stop Injection Needle recalled for incorrect expiration date labeling

Hobbs Medical recalled Posi-Stop Injection Needles with incorrect expiration dates on labels, potentially allowing use of units past actual expiration. The recall affects 17 units distributed in the US and several countries.

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 hospitalizations or injuries. The hazard is theoretical—devices may be used past actual expiration—making this a risk-of-harm product with no yet-reported harm, which scores as High (3) per the rubric.

Plain-English summary

Hobbs Medical, Inc. has recalled Posi-Stop Injection Needles (Catalog Number 4722, UDI-DI: M84947220) due to incorrect expiration dates displayed on device labels. The incorrect dating extends the labeled shelf life beyond the actual expiration, creating a risk that users may unknowingly utilize expired sterile medical devices.

The recall affects 17 units with lot number H06-18-046R, distributed worldwide from March 25, 2018 through September 28, 2020. Affected devices carry expiration dates between November 1, 2022 and September 1, 2025 on their labels. Distribution included the United States and Canada, Austria, Belgium, Finland, and Norway.

Healthcare facilities and individuals in possession of these devices should identify any Posi-Stop Injection Needles with the affected lot number (ending in "R"). Such devices should not be used, as the actual sterility and integrity of the product cannot be assured. Contact Hobbs Medical, Inc. for instructions on return or proper disposal.

The recalled product

Product
Hobbs Posi-Stop Injection Needle Catalog Number: 4722
Manufacturer
Hobbs Medical, Inc.
Hazard
  • mis-labeling
  • sterility-risk

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 (1)

  • UDI-DI:M84947220 Lot Numbers: H06-18-046R

Distribution

Distributed nationwide across the United States.