The Recall Desk
HighFDA (Devices)·Z-0030-2023·Announced 2022-10-19

Hobbs Helical Retrieval Basket Recall Due to Incorrect Expiration Date

Hobbs Medical is recalling Helical Retrieval Baskets (Catalog 4822) with incorrect expiration dates on device labels. The mislabeled dates extend the shelf life, risking use of expired devices that may not perform as intended.

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 recall involving labeling error where expiration dates are incorrect, potentially extending shelf life. While no illnesses or injuries have been reported and the hazard is theoretical, this represents a risk-of-harm situation where medical devices may be used beyond their intended shelf life and fail to perform correctly.

Plain-English summary

Hobbs Medical, Inc. is recalling the Hobbs Helical Retrieval Basket (Catalog Number 4822) due to incorrect expiration dates printed on device labels. The labels display expiration dates between November 1, 2022 and September 1, 2025, but these dates are incorrect and extend the actual shelf life of the product.

The affected devices were distributed in the United States from March 25, 2018 to September 28, 2020. Affected units are identified by lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R". The specific lot numbers involved are H11-17-161R and H02-17-102R. The product was also distributed worldwide to Canada, Austria, Belgium, Finland, and Norway.

Using expired retrieval baskets may result in device malfunction or failure to perform as intended during medical procedures. Healthcare facilities and individuals in possession of this product should verify lot numbers against the information provided and contact Hobbs Medical, Inc. for instructions on returning or replacing affected devices.

The recalled product

Product
Hobbs Helical Retrieval Basket Catalog Number: 4822
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Surgical Intervention
Hazard
  • mis-labeling
  • expired-device

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: M84948220 Lot Numbers: H11-17-161R H02-17-102R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category