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EZDilate

Gyrus ACMI, LLC · Model BD-410X-1555 · UDI-DI 00821925033252

KNQ Prescription

510(k) clearances

5,289

Adverse events (16 deaths)

Recalls

Facilities

Description

EZDilate 3-Stage Balloon Dilator (Wire Guided) 13.5-14.5-15.5 mm diameter

Recalls

Date	Firm	Reason
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2013-05-28	Boston Scientific Corporation	Product labeled with incorrect expiration date.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.