Olympus POWERSEAL 5mm 23cm Sealer Recall: Incorrect Labeling Risk
Olympus recalls POWERSEAL 5mm 23cm curved jaw sealers due to potential mislabeling as 37cm devices. Affected units may be confused with larger models.
Lower-risk recall
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
What happened, in plain English
Olymp: Olympus is recalling POWERSEAL 5mm (23cm) curved jaw sealers because they might be incorrectly labeled as 37cm devices. This could lead to confusion with larger models that may not fit properly. Read more at govinfonow.com/recall/697844-olympus-powerseal-5mm-23cm-sealer-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/697844-olympus-powerseal-5mm-23cm-sealer-recall-incorrect-labeling-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-3035-2026
Cite this page
“Olympus POWERSEAL 5mm 23cm Sealer Recall: Incorrect Labeling Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697844-olympus-powerseal-5mm-23cm-sealer-recall-incorrect-labeling-risk. Based on FDA recall #Z-3035-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3035-2026%22&limit=1).
Why it’s dangerous
The sealers might be mislabeled as 37cm devices when they are actually 23cm. This could cause improper use if the wrong size is selected for a procedure.
Who’s affected
Healthcare professionals using these surgical sealers in medical settings. Patients using the sealers during procedures may be at risk if the wrong size is used.
How to tell if you have this one
Check for model number PS-0523CJDA on the product. The device is 23cm long, not 37cm. Look for lot number FR490902 on the packaging.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Product Label
Verify the model number is PS-0523CJDA and the device is 23cm long, not 37cm.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Kansas.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
The recall does not require action; check the label to confirm the correct size.
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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-3035-2026 (August 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3035-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 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.