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

Lot, batch or date codesModel Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.

Quantity recalled335 units

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.

Nationwide Florida Kansas

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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