Hobbs Medical Polypectomy Snare Recalled for Incorrect Expiration Date
Hobbs Medical is recalling Polypectomy Snare devices (Catalog Number 4564) due to incorrect expiration dates on labels that extend the stated shelf life. The 35 affected units, distributed in the US and select countries, may be used beyond their actual safe shelf life.
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: FDA Class II medical device with incorrect expiration dating. While no illnesses or injuries have been reported, the recall addresses a risk-of-harm scenario where surgical devices may be used beyond their safe shelf life, potentially compromising sterility and device integrity in invasive procedures.
Plain-English summary
Hobbs Medical, Inc. is recalling Polypectomy Snare devices (Catalog Number 4564) distributed between March 25, 2018, and September 28, 2020. The recall affects 35 units distributed nationwide in the United States and internationally in Canada, Austria, Belgium, Finland, and Norway.
The devices have incorrect expiration dates printed on their labels. The incorrect dates extend the stated shelf life beyond the actual safe shelf life of the product. This labeling error could result in use of devices that may no longer meet safety and performance standards.
Affected devices are identifiable by lot numbers ending in 'R' or by kits containing at least one device with a lot number ending in 'R'. The specific lot numbers involved are H02-18-198R and H09-17-027R. Affected devices display expiration dates between November 1, 2022, and September 1, 2025.
Healthcare facilities and users in possession of affected devices should discontinue use immediately. Contact Hobbs Medical, Inc. for instructions on device return or replacement. The FDA classified this as a Class II recall.
The recalled product
- Product
- Hobbs Medical Polypectomy Snare Catalog Number: 4564
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- incorrect-expiration-date
- mislabeling
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: M84945640 Lot Numbers: H02-18-198R H09-17-027R
Distribution
Distributed nationwide across the United States.
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