Aomori Olympus Recalls KD-612U Electrosurgical Snare Due to Seal Defects
Aomori Olympus is recalling KD-612U electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
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 KD-612U Electrosurgical Snare, model no. KD-612U. This medical device is used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. The recall involves 260,395 units in the United States, with a global total of 7,400,000 units. The affected products were distributed nationwide in the US.
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 in this context may lead to patient infections.
Healthcare providers and consumers should stop using the affected KD-612U Electrosurgical Snare units immediately. Affected lots are identified by the following codes: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK. Users should contact the recalling firm for further instructions on returning or replacing the devices.
The recalled product
- Product
- KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper 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 (15)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
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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