CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled
Olympus Corporation of the Americas is recalling Powerseal (in diameter) (long), Curved Jaw Sealer & Divider, Double Action, distributed nationwide in the US. The recall was initiated on 18 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3035-2026
- FDA event ID
- 99607
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2026
- FDA classified
- 26 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 18 Aug 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +8 days |
| 2 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Product as listed by the FDA
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Where it was distributed
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Questions about this recall
Why was it recalled?
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Which lots are affected?
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
Where was it sold?
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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