Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information
Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall involving mislabeling of critical device specifications. Although no illnesses or injuries have been reported, the incorrect sizing information poses a risk of harm through inadequate dilation or procedural complications, fitting the 'risk-of-harm where injury has not yet been reported' criterion.
Plain-English summary
Olympus Corporation of the Americas is recalling 209 units of the EZDilate Wire Guided Balloon (Model BD-410X-1055, Lot 408987) due to incorrect sizing information on the product label. The Glo Cath label attached to the device states that the balloon sizes are 11 mm, 12 mm, and 13 mm, when the actual balloon dimensions are 8.5 mm, 9.5 mm, and 10.5 mm. All other labeling, including the shelf box and packaging labels, is correct.
The EZDilate Wire Guided Balloon is indicated for use in adults and adolescents over 12 years old to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilation of the Sphincter of Oddi with or without prior sphincterotomy.
The mismatch between the labeled and actual balloon sizes may result in prolonged surgery. Healthcare providers who have received this product should verify the actual balloon dimensions before use and adjust procedures accordingly. This product was distributed to multiple US states and internationally.
The recalled product
- Product
- EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.…
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 209
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)
- UDI-DI: 821925033238 Lot: 408987
Distribution
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