The Recall Desk
ModerateFDA (Devices)·Z-0029-2023·Announced 2022-10-19

Hobbs Helical Retrieval Basket Recall: Incorrect Device Label Expiration Date

Hobbs Medical is recalling Helical Retrieval Baskets due to incorrect expiration dates on device labels. The mislabeling extends the shelf life, potentially allowing use of expired devices.

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: This is a Class II medical device recall due to a labeling error involving expiration date. No hospitalizations, serious injuries, or deaths have been reported. The recall addresses a potential risk from using expired devices, but without documented adverse events, the severity is moderate.

Plain-English summary

Hobbs Medical, Inc. is recalling Hobbs Helical Retrieval Baskets (Catalog Number 4816) due to incorrect expiration dates printed on device labels. The labels display expiration dates that extend the actual shelf life of the product, creating a risk that healthcare facilities or users may unknowingly use devices past their intended safe-use period.

The affected devices were distributed in the United States between March 25, 2018 and September 28, 2020, with label expiration dates ranging from November 1, 2022 to September 1, 2025. Affected units have lot numbers ending in 'R' or are kits containing at least one device with a lot number ending in 'R' (UDI-DI: M84948160). The devices were also distributed worldwide to Canada, Austria, Belgium, Finland, and Norway.

Using a medical device past its actual expiration date may compromise device integrity, sterility, or performance. Patients and healthcare facilities should stop using affected devices and contact Hobbs Medical or their supplier for instructions on device return or replacement.

The recalled product

Product
Hobbs Helical Retrieval Basket Catalog Number: 4816
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • mislabeling
  • shelf-life-extension
  • device-degradation

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: M84948160 Lot Numbers: H03-18-168R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category