Smart Stapes Protheses Piston 0 — Class II medical device recall Z-2814-2020
Terminated recall by Olympus Corporation of the Americas, reported 2020-08-26, distributed in CA, FL, GA, PA. Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Pis
| Recall number | Z-2814-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2020-07-14 |
| Classified | 2020-08-14 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2021-09-07 |
| Distributed | CA, FL, GA, PA |
| Countries outside the US | CH, NZ |
| Quantity | 21 units |
| Reason classes | labeling |
| Lot numbers | PR911937 |
| Model numbers | 70143662 |
Product
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2814-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.