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Olympus PowerSeal 5 mm Curved Jaw Sealer & Divider
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MEDICAL DEVICE RECALLMODERATE

Olympus PowerSeal 5 mm Curved Jaw Sealer & Divider

Olympus recalls PowerSeal 5 mm Curved Jaw Sealer & Divider over labeling error.

What to do

Check the outer shelf box labeling of your PowerSeal 5 mm device to ensure it matches the actual device size. If the box is labeled as 37 cm but the device is 23 cm, stop using it and contact Olympus for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
Z-3035-2026
Agency
FDA
Firm
Olympus Corporation of the Americas
Recall ID
99607
Status
ONGOING

Recall at a glance

Quantity recalled
335 units

Why it was recalled

Olympus Corporation of the Americas is recalling the PowerSeal 5 mm Curved Jaw Sealer & Divider, 23 cm, due to a labeling deficiency where the outer shelf box may be incorrectly labeled as a 37-cm device. This could lead to use of the wrong device size during surgery.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories

Lot code
FR490902
UDI-DI
00821925044531

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification