The Recall Desk

FDA (Devices) recall action 86045

Olympus Corporation of the Americas recalled 2 products on 2020-08-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-08-26
Critical
0
Units
37

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2020-08-26

    Olympus Smart Stapes Protheses Piston Recalled for Mislabeled Outer Carton

    Olympus is recalling 21 units of Smart Stapes Protheses Piston because the outer carton was mislabeled, potentially containing a different model.

    Product
    Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2020-08-26

    Olympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices

    Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston due to outer carton mislabeling.

    Product
    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
    Category
    Distribution
    4 states