FDAClass II · Medical device · Recall Z-3035-2026 · Recalled September 2, 2026

POWERSEAL 5 MM (in diameter) 23 CM (long) recall — Olympus Corporation of the Americas

Agency report date: September 2, 2026.

1. Compare your item

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.

Product named: POWERSEAL 5 MM (in diameter) 23 CM (long)
Company / brand: Olympus of the Americas
Lot / serial / date codes: Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
Distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.

Agency product description and boundaries

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.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: POWERSEAL 5 MM (in diameter) 23 CM (long) recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3035-2026
Brand: All Olympus of the Americas recalls
Classification: Class II
Units affected: 335 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

POWERSEAL 5 MM (in diameter) 23 CM (long) recall status

Companies & origin

Recalling firm location: Center Valley, PA, United States
Firm address: 3500 Corporate Pkwy, N/A, 18034-8229

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
Distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Firm notified the public via: Letter
FDA event ID: 99607
Recall initiated: August 18, 2026
FDA classified: August 26, 2026
FDA report date: September 2, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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