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.
What this means for you
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 and involves a minor labeling error (mislabeled outer carton) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement, Catalog Number 70142168. The recall is due to a labeling error where the outer carton was labeled as containing the 70143662 Smart Piston, while the inside package actually contained the 70142158 Stapes Piston.
The affected units are identified by Lot number PR898678. Distribution records indicate the products were shipped to California, Florida, Georgia, and Pennsylvania, as well as to New Zealand and Switzerland.
Healthcare providers and consumers should stop using the affected products and contact Olympus Corporation of the Americas for further instructions or a return.
The recalled product
- Product
- Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Otolaryngology
- Hazard
- Affected units
- 16
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: PR898678
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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