The Recall Desk
HighFDA (Devices)·Z-0024-2023·Announced 2022-10-19

Hobbs Posi-Stop Injection Needles Recalled for Incorrect Expiration Date Labeling

Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles with lot numbers ending in 'R' due to incorrect expiration dates on device labels. The mislabeling extends the apparent shelf life, potentially allowing use of expired sterile devices.

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 a Class II FDA medical device recall for incorrect expiration date labeling on sterile injection needles. Although injection needles are inherently risk-of-harm medical devices and the mislabeling could result in use of expired, potentially compromised devices, no illnesses or injuries have been reported. Per the severity rubric, recalls of risk-of-harm products without reported injury are scored as High.

Plain-English summary

Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles (Catalog Number 4720) that were distributed between March 25, 2018 and September 28, 2020. Affected units have lot numbers ending in 'R' or are kits containing at least one device with a lot number ending in 'R', including Lot Number H03-18-152R. A total of 50 units have been identified as affected.

The device labels display incorrect expiration dates, extending the shelf life of the product beyond its actual usable period. Using expired sterile injection needles could compromise device sterility and pose a safety risk to patients.

The affected devices were distributed worldwide to locations including the United States, Canada, Austria, Belgium, Finland, and Norway.

Healthcare providers and consumers who possess Posi-Stop Injection Needles with lot numbers ending in 'R' should discontinue use immediately. Contact Hobbs Medical, Inc. or your healthcare provider for instructions on device return or replacement. This is a Class II FDA recall.

The recalled product

Product
Hobbs Posi-Stop Injection Needle Catalog Number: 4720
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Injection Needle
Hazard
  • expiration-mislabeling
  • 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:M84947200 Lot Numbers: H03-18-152R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category