Olympus Spiration Valve System: Mislabeled Model Risk

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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, N/A · Center Valley, PA 18034-8229

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling Spiration Valve System (SVS) cartridges that have a mislabeled patient charge label showing a 7mm model (SVS-V7-00) instead of the correct 9mm model (SVS-V9-00). This mismatch could cause improper use during medical procedures.

Why it’s dangerous

The mislabeled cartridge (SVS-V7-00) is smaller than the intended model (SVS-V9-00). Using the wrong size could cause improper function during medical procedures, potentially leading to ineffective treatment or complications.

Who’s affected

Adult patients using the Spiration Valve System for breathing issues may be affected if they have the mislabeled cartridge. Healthcare providers using the system are most at risk of administering the wrong size.

How to tell if you have this one

Check for a patient charge label showing SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm). Affected units were sold with lot number WS147887-01 and expiration date 4/30/2024.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Label
Verify the patient charge label shows SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm).

✎ GovInfoNow

Questions people ask

What is the correct model number for the Spiration Valve System?

The correct model number is SVS-V9-00 (9mm).

How can I tell if I have the recalled cartridge?

Check the patient charge label for SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm). Affected units have lot number WS147887-01 and expire 4/30/2024.

What should I do if I have the mislabeled cartridge?

The recall does not specify a remedy, so contact Olympus directly for guidance.

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-0551-2022 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-0551-2022 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-0551-2022 (December 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0551-2022 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 Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with

Lower-risk recall