Aomori Olympus Recalls KD-612L Electrosurgical Knives Due to Seal Defects
Aomori Olympus is recalling KD-612L electrosurgical knives because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and cause 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-612L Electrosurgical Knife, model no. KD-612L. This device is used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. The recall affects 7,400,000 units globally and 260,395 units in the United States, with nationwide distribution.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. If non-sterile equipment is used, patients may develop infections.
Healthcare providers and facilities should stop using the affected KD-612L Electrosurgical Knives and contact Aomori Olympus Co., Ltd. for instructions on how to return or dispose of the devices. The affected product codes are 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
The recalled product
- Product
- KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - 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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