The Recall Desk
ModerateFDA (Devices)·Z-0033-2023·Announced 2022-10-19

Hobbs Helical Retrieval Basket Recalled for Incorrect Expiration Date

Hobbs Medical, Inc. is recalling Hobbs Helical Retrieval Baskets with lot numbers ending in R due to incorrect expiration dates on device labels. Affected units were distributed worldwide from March 2018 to September 2020.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for a labeling error with incorrect expiration date information. No illnesses, injuries, or deaths are reported in the source text, and the hazard is precautionary in nature involving extended shelf life.

Plain-English summary

The Hobbs Helical Retrieval Basket (Catalog Number 4832), manufactured by Hobbs Medical, Inc., is being recalled. Affected devices are identified by lot numbers ending in R, including lots H11-17-162R and H01-17-137R.

Device labels on affected units display an incorrect expiration date that extends the shelf life beyond the product's tested period.

Approximately 13 units were distributed worldwide, including the United States and Canada, Austria, Belgium, Finland, and Norway. Distribution occurred between March 25, 2018, and September 28, 2020. Affected devices include those with expiration dates between November 1, 2022, and September 1, 2025, with lot numbers ending in R, or kits containing at least one device with a lot number ending in R.

Consumers and healthcare facilities should identify affected devices by checking lot numbers and contact Hobbs Medical, Inc., for instructions on replacement or further guidance.

The recalled product

Product
Hobbs Helical Retrieval Basket Catalog Number: 4832
Manufacturer
Hobbs Medical, Inc.
Hazard
  • expiration-date-mislabeling
  • shelf-life-extension

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: M84948320 Lot Numbers: H11-17-162R H01-17-137R

Distribution

Distributed nationwide across the United States.