The Recall Desk
HighFDA (Devices)·Z-0019-2023·Announced 2022-10-19

Hobbs Scope Introducer Recalled for Incorrect Label Expiration Date

Hobbs Medical is recalling 140 units of its Hobbs Scope Introducer due to incorrect label expiration dates that extend the shelf life. Affected devices were distributed in the US and internationally from March 2018 to September 2020.

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 device recall involving a labeling error that compromises device safety. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score per the rubric.

Plain-English summary

Hobbs Medical, Inc. is recalling 140 units of the Hobbs Scope Introducer (Catalog Number 4650) because the device label displays an incorrect expiration date. This mislabeling extends the stated shelf life beyond the actual safe period for the product.

Medical devices used past their actual expiration date may not function as intended or may pose safety risks to patients. The affected devices have label expiration dates ranging from November 1, 2022 to September 1, 2025.

The recalled devices were distributed worldwide to the United States and internationally to Canada, Austria, Belgium, Finland, and Norway. Distribution occurred between March 25, 2018 and September 28, 2020. The affected lot numbers are H04-18-182R and H04-18-181R, or any kits containing at least one device with a lot number ending in R.

Users and healthcare facilities should discontinue use of scope introducers from the affected lot numbers and contact Hobbs Medical or their supplier for further guidance. Patients who may have received care involving these devices should consult with their healthcare provider.

The recalled product

Product
Hobbs Scope Introducer Catalog Number: 4650
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Scope Introducer
Hazard
  • mis-labeling
  • incorrect-expiration-date

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: M84946500 Lot Numbers: H04-18-182R H04-18-181R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category