Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Recalled by Olympus Corporation of the Americas Due to Mislabeling
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 Olympus Corporation of the Americas directly.
Affected Products
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Quantity: 21 units
Why Was This Recalled?
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
Where Was This Sold?
This product was distributed to 4 states: CA, FL, GA, PA
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report