Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-210U-25 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of 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 infection from non-sterile equipment, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the SD-210U-25 Electrosurgical Snare. This device is used with endoscopes to electrosurgically resect tissue within the digestive tract. The recall involves 260,395 units distributed in the United States, with 7,400,000 units affected globally.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment may result in patients developing infections.
The affected products were distributed nationwide in the US. Specific lot codes are listed in the recall documentation. Healthcare providers and consumers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-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 (20)
- 03K
- 04K
- 05K
- 07K
- 08K
- 09K
- 0XK
- 92K
- 93K
- 94K
- 95K
- 96K
- 97K
- 98K
- 99K
- 97V
- 98V
- 99V
- 9XV
- 03V
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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