The Recall Desk
HighFDA (Devices)·Z-0020-2023·Announced 2022-10-19

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

Hobbs Medical is recalling Hobbs Posi-Stop Injection Needles with certain lot numbers because device labels display an incorrect expiration date, extending the product's indicated shelf life.

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 recall involving a risk-of-harm medical device (injection needle) where labeling errors could result in use of expired or compromised devices. Although no injuries have been reported, the potential for harm to patients justifies a High severity rating.

Plain-English summary

Hobbs Medical, Inc. is recalling Hobbs Posi-Stop Injection Needles (Catalog Number 4702) due to incorrect expiration dates displayed on device labels. The labeling error extends the indicated shelf life of the product, which could affect device safety and sterility.

The recalled devices were distributed worldwide, including throughout the United States and the countries of Canada, Austria, Belgium, Finland, and Norway, between March 25, 2018 and September 28, 2020. Affected devices have lot numbers ending in "R" or are kits containing at least one device with a lot number ending in "R." Expiration dates on affected units range from November 1, 2022 to September 1, 2025.

Patients and healthcare providers should verify lot numbers on device labels. Devices with lot numbers ending in "R" should not be used. Users should contact Hobbs Medical, Inc. for guidance on replacement or proper disposal of affected units.

The U.S. Food and Drug Administration classified this as a Class II recall. For more information, visit the FDA's official recall page at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-0020-2023.

The recalled product

Product
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Injection Needle
Hazard
  • expiration-date-error
  • sterility

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:M84947020 Lot Numbers: H10-17-062R H10-17-062R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category