Hobbs Helical Retrieval Basket Recalled for Incorrect Expiration Date Labels
Hobbs Medical is recalling Helical Retrieval Baskets with incorrect expiration dates that extend shelf life. Devices distributed from March 2018 through September 2020 may be used beyond their safe operating period.
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 a risk-of-harm medical device recall (Class II) where no illnesses or injuries have been reported. The hazard of using expired retrieval baskets during patient procedures poses a potential risk, but device failure has not yet caused reported harm.
Plain-English summary
Hobbs Medical, Inc. is recalling Hobbs Helical Retrieval Baskets (Catalog Number 4808) due to incorrect expiration dates printed on device labels. The labels display expiration dates that extend the shelf life beyond the actual safe operating period, which could result in use of expired medical devices during procedures.
The affected devices were distributed in the United States and internationally (Canada, Austria, Belgium, Finland, Norway) between March 25, 2018 and September 28, 2020. Lot numbers ending in "R" are affected, as are kits containing at least one device with a lot number ending in "R." The incorrect expiration dates on affected labels range from November 1, 2022 through September 1, 2025.
Healthcare facilities and practitioners who use retrieval baskets should check their inventory for affected lot numbers and verify expiration dates against product documentation. Do not use devices that may be beyond their actual safe operating period. Contact Hobbs Medical, Inc. for replacement or additional information.
The recalled product
- Product
- Hobbs Helical Retrieval Basket Catalog Number: 4808
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 2
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: M84948080 Lot Numbers: H02-18-113R
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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