Olympus Smart Stapes Protheses Piston Recall: Mislabeled Carton Risk

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Contact the company & request your remedy

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling Smart Stapes Protheses Pistons (Catalog 70142168) because the outer carton labels them incorrectly. This mislabeling might cause users to receive the wrong product, which could lead to improper use.

Why it’s dangerous

The outer carton label states the product is the 70143662 Smart Piston, but the actual contents are the 70142158 Stapes Piston. This mislabeling could lead to users receiving the wrong product, potentially causing improper use.

Who’s affected

People who own or use the Smart Stapes Protheses Piston 0.4mm X 5.25mm (Catalog 70142168) are affected. Those most at risk are individuals who rely on this specific product for hearing assistance.

How to tell if you have this one

Check for the catalog number 70142168 on the product. The product was sold with lot number PR898678.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the catalog number 70142168 and lot number PR898678 on the product.

✎ GovInfoNow

Questions people ask

What is the catalog number for the recalled product?

The catalog number is 70142168.

What is the lot number for the recalled product?

The lot number is PR898678.

Why is this product being recalled?

The outer carton label states the product is the 70143662 Smart Piston, but the actual contents are the 70142158 Stapes Piston.

Take action

Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2813-2020 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-2813-2020 from Olympus.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2813-2020 (July 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2813-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Olympus Corporation of the Americas recalls Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

Lower-risk recall