Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-25 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of infection from non-sterile equipment, which aligns with the rubric for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the SD-240U-25 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 a total of 7,400,000 units affected globally. The specific lot codes involved are 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, and 07V.
The recall was initiated after inspections confirmed that a small percentage of the sterile packages have inadequate package seals, specifically partial heat seals. This defect compromises the sterility of the equipment. If non-sterile equipment is used during a procedure, patients may develop infections.
Healthcare providers and facilities should stop using the affected electrosurgical snares immediately. Users should check their inventory for the specific lot codes listed above and contact the manufacturer for further instructions on how to handle or return the affected units.
The recalled product
- Product
- SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - 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
- 99V
- 9XV
- 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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