FDAClass II · Medical device · Recall Z-3216-2026 · Recalled September 30, 2026

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall — Olympus Corporation of the Americas

Agency report date: September 30, 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: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11
Company / brand: Olympus of the Americas
Lot / serial / date codes: Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
Distribution: International distribution in the country of Japan.

Agency product description and boundaries

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

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 for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

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: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3216-2026
Brand: All Olympus of the Americas recalls
Classification: Class II
Units affected: 305 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall status

Companies & origin

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

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
Distribution: International distribution in the country of Japan.
Firm notified the public via: E-Mail
FDA event ID: 99627
Recall initiated: August 19, 2026
FDA classified: September 18, 2026
FDA report date: September 30, 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 ↗

Found something wrong or missing? Report a data error.

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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