Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
Olympus is recalling 305 units of EZDilate Endoscopic Balloon Dilators because the inflation chart label may incorrectly indicate balloon diameters of 18, 19, or 20 mm.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Olympus Corporation of the Americas is recalling 305 units of the EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm (Model Number: BD-420X-1355). The recall is due to a potential error where the inflation chart label affixed to the device shaft may be incorrect and indicate a balloon diameter of 18, 19, or 20 mm.
The affected devices were distributed internationally in Japan. The specific lot number is 460898, and the UDI-DI is 00821925042261. The source text does not specify the exact date of distribution or the specific healthcare facilities affected.
Healthcare providers and consumers should stop using the affected devices and contact Olympus Corporation of the Americas for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 305
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
Distribution
Distribution scope not specified by the agency.
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