Aomori Olympus Recalls KD-620UR Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-620UR Electrosurgical Snare units because inspection found inadequate package seals, which could compromise sterility and lead to patient 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-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 KD-620UR Electrosurgical Snare, model no. KD-620UR. 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 distributed nationwide in the United States, with a global total of 7,400,000 units. Affected units are identified by the following codes: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
The recall was initiated after inspection confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment poses a risk that patients may develop infections. The agency has classified this recall as Class II.
Healthcare providers and consumers should stop using the affected KD-620UR Electrosurgical Snare units immediately. Users should check their inventory for the specific model number and lot codes listed above. For further instructions on how to return or dispose of the recalled devices, contact the recalling firm, Aomori Olympus Co., Ltd.
The recalled product
- Product
- KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - 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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