Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-10 electrosurgical snares because inspection found inadequate package seals. Non-sterile equipment use may lead to patient infection.
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: The recall involves a risk-of-harm product (infection from non-sterile equipment) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the SD-240U-10 Electrosurgical Snare, model no. SD-240U-10. This medical device is used with endoscopes to electrosurgically resect tissue within the digestive tract. The recall involves 7,400,000 units globally and 260,395 units in the United States, with nationwide distribution in the US. Affected lot codes include 97V, 99V, 9XV, 9YV, 03V, 04V, 05V, 06V, and 07V.
The recall was initiated after inspection confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The hazard is that patients may develop infections if non-sterile equipment is used during procedures.
Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
- Manufacturer
- Aomori Olympus Co., Ltd.
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 (9)
- 97V
- 99V
- 9XV
- 9YV
- 03V
- 04V
- 05V
- 06V
- 07V
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 111 recalled by Aomori Olympus Co., Ltd. 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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