Recall Z-3035-2026— Olympus Corporation of the Americas

Name: FDA recall Z-3035-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-18

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-08-18. It names one FDA 510(k) clearance: K212643. Product: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories. Reason: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-08-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K212643 — POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America·cleared 2021-09-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Data sourced from openFDA. This site is unofficial and independent of the FDA.