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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 14
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.
Part of a larger recall action
This product is one of 61 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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