Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-230U-20 electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.
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 risk from non-sterile equipment) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the SD-230U-20 Electrosurgical Snare, a medical device used with endoscopes to resect tissue within the digestive tract. The recall affects 260,395 units distributed nationwide in the United States, with lot codes 97V, 98V, 9XV, 9YV, 03V, 04V, 05V, 06V, and 07V.
The recall was initiated after inspections confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.
Healthcare providers and consumers should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - 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
- 98V
- 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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