Olympus Spiration Valve System: Mislabeled Model Risk
Olympus recalls Spiration Valve System (SVS) cartridges with incorrect model labels that could lead to improper patient use. Affected units have SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm).
Lower-risk recall
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Contact the company
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. Read more at govinfonow.com/recall/61342-olympus-spiration-valve-system-mislabeled-model-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61342-olympus-spiration-valve-system-mislabeled-model-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0551-2022
Cite this page
“Olympus Spiration Valve System: Mislabeled Model Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61342-olympus-spiration-valve-system-mislabeled-model-risk. Based on FDA recall #Z-0551-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2022%22&limit=1).
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
What to do — step by step
Check Label
Verify the patient charge label shows SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Massachusetts, New Jersey, Pennsylvania, South Carolina, Texas, Wisconsin.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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.