Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-203 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 harm (infection) from a sterile integrity defect, but the source text does not report any actual illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the K-203 Guide Sheath Kit 2.6MM (model no. K-203). These medical devices are used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall affects 260,395 units distributed in the United States, with 7,400,000 units affected globally.
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.
The affected products were distributed nationwide in the US. The specific lot codes involved are 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, and 9ZK. Healthcare providers and consumers should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - 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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