Aomori Olympus Recalls K-204 Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-204 Guide Sheath Kits 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 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 K-204 GUIDE SHEATH Kit 2.6MM (model no K-204). These medical devices are used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall affects 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 sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment due to these seal defects may result in patients developing infections.
Healthcare providers and facilities should stop using the affected K-204 GUIDE SHEATH Kits and contact Aomori Olympus Co., Ltd. for instructions on returning or disposing of the products. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns about potential infection.
The recalled product
- Product
- K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- 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 (17)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 95K
- 96K
- 97K
- 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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