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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error (mislabeled outer carton) rather than a direct contamination or structural defect, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Olympus Corporation of the Americas is recalling 21 units of Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement, Catalog Number 70143662. The recall is due to a labeling error where the outer carton stated the contents were the 70143662 Smart Piston, but the inside package actually contained the 70142158 Stapes Piston.
The affected units were distributed in California, Florida, Georgia, and Pennsylvania, as well as in New Zealand and Switzerland. The specific lot number for the recalled product is PR911937.
Healthcare providers and consumers should check their inventory for this specific catalog number and lot number. If the outer carton label does not match the internal package contents, the product should be returned to Olympus Corporation of the Americas for credit or replacement.
The recalled product
- Product
- Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 21
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 (1)
- Lot number: PR911937
Distribution
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas 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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