Hobbs Medical Polypectomy Snare Recalled for Incorrect Expiration Dates
Hobbs Medical is recalling polypectomy snares with incorrect expiration dates on labels. Affected devices have lot numbers ending in R and were distributed from March 2018 to September 2020.
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: FDA Class II recall with labeling defect (incorrect expiration date). No reported illnesses or injuries. The hazard is theoretical rather than confirmed.
Plain-English summary
Hobbs Medical, Inc. is recalling the Polypectomy Snare (Catalog Number 4563-OLY) because the device label displays an incorrect expiration date. The label extends the shelf life beyond the actual product shelf life. Affected devices have lot numbers ending in R.
These devices were distributed in the United States between March 25, 2018 and September 28, 2020. They also were distributed to Canada, Austria, Belgium, Finland, and Norway. Affected labels show expiration dates between November 1, 2022 and September 1, 2025.
Polypectomy snares are medical devices used in endoscopic procedures. Using an expired device may compromise the safety and effectiveness of the procedure. No illnesses or injuries related to this issue have been reported.
Consumers who possess affected devices should contact Hobbs Medical, Inc. to determine if their device is included in the recall based on lot number. Facilities should verify their inventory for devices with lot numbers ending in R and expiration dates within the affected range.
The recalled product
- Product
- Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 30
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: M8494563OLY0 Lot Numbers: H03-18-137R
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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