Hobbs Helical Retrieval Basket recalled for incorrect expiration date
Hobbs Medical recalled 10 units of its Helical Retrieval Basket due to mislabeled expiration dates that extend the product's shelf life, affecting devices distributed in the US and select countries between 2018 and 2020.
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 a Class II medical device recall involving a labeling defect that extends shelf life, creating risk of harm through potential use of expired medical devices. No illnesses or injuries have been reported, which per the rubric limits the maximum score to 3 for theoretical hazards without reported harm.
Plain-English summary
Hobbs Medical, Inc. is recalling the Hobbs Helical Retrieval Basket (Catalog Number 4824) due to an error in the device labeling. The expiration dates printed on device labels are incorrect and extend the shelf life of the product beyond its actual safe usable period.
The affected devices have lot numbers ending in "R" and were distributed worldwide, including throughout the United States, Canada, Austria, Belgium, Finland, and Norway. Distribution occurred between March 25, 2018 and September 28, 2020. The incorrect labels display expiration dates ranging from November 1, 2022 to September 1, 2025.
Healthcare facilities and medical professionals in possession of affected units should discontinue use and contact Hobbs Medical, Inc. for product verification and instructions. Devices with incorrect expiration dates should not be used, as expired medical devices may not perform as intended and could compromise patient safety.
The recalled product
- Product
- Hobbs Helical Retrieval Basket Catalog Number: 4824
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 10
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: M84948240 Lot Numbers: H02-17-159R
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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