Olympus Corporation of the Americas — Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Official product recall notices and clearly labeled enforcement reference records.
Reference record — not a live warning · enforcement-reference · official-source
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,
- Posted by source
- Source last updated
- Current version retrieved
- Provider
- FDA — device enforcement reference
- Location
- Center Valley, PA, US
- hazard
- 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,
- notice
- Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
- product
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- distribution
- International distribution in the country of Japan.
- event number
- 99627
- manufacturer
- Olympus Corporation of the Americas
- recall number
- Z-3216-2026
- source status
- Open, Classified
- freshness minutes
- 180
Source use policy · openFDA reference data; not a real-time public alert service
Update history (1 recent revisions)
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