Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-202 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 is classified as FDA Class II. The hazard involves a risk of infection from non-sterile equipment, which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the K-202 GUIDE SHEATH Kit 2.0MM (model no. K-202). These medical devices are used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall involves 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. The use of non-sterile equipment presents a risk that patients may develop infections.
Healthcare providers and consumers should stop using the affected K-202 GUIDE SHEATH Kits immediately. Affected lots include codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, and 9ZK. Users should contact the manufacturer for further instructions on returning or disposing of the product.
The recalled product
- Product
- K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - 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 (18)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 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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