Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
K-203 GUIDE SHEATH KIT 2.6MM Recalled by Aomori Olympus Co., Ltd. Due to Inspection confirmed a small percentage of sterile packages...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aomori Olympus Co., Ltd. directly.
Affected Products
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.
Quantity: 7,400,000 (globally); 260,395 (US)
Why Was This Recalled?
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aomori Olympus Co., Ltd.
Aomori Olympus Co., Ltd. has 113 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report