Notice names this product. Olympus of the Americas’s POWERSEAL 5 MM (in diameter) 23 CM (long) is named in FDA Class II recall Z-3035-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. Identifying details: Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.. Units affected: 335 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Company / brand: Olympus of the Americas recalls
Affected product: POWERSEAL 5 MM (in diameter) 23 CM (long) recall status
Official ID Z-3035-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 23, 2026 at 6:00 PM UTC.