Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-210U-10 electrosurgical snares because inspection found 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 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-210U-10 Electrosurgical Snare, model no. SD-210U-10. This medical device is used with endoscopes to electrosurgically resect tissue within the digestive tract. The recall involves 260,395 units in the United States, with a global total of 7,400,000 units. The products were distributed nationwide in the US.
The recall was initiated after inspections confirmed that a small percentage of the sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment during medical procedures may lead to patient infections.
Healthcare facilities and consumers should stop using the affected devices immediately. Affected lots include codes 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, and 9YV. Users should contact the recalling firm for further instructions on returning or replacing the devices.
The recalled product
- Product
- SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-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 (20)
- 01K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 92K
- 93K
- 95K
- 96K
- 97K
- 98K
- 99K
- 9XK
- 97V
- 98V
- 99V
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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