Aerin Medical VivAer Stylus Recall: Programming Error Causes Device Misidentification
Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.
What this means for you
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: FDA Class II device with a programming defect causing device misidentification. No illnesses, injuries, or deaths have been reported. The defect is functional rather than structural, classifying it as a risk-of-harm product without reported injury.
Plain-English summary
Aerin Medical, Inc. is recalling 479 units of the VivAer Stylus, a sterile medical device. The recall affects units from Lot #10235 (expiration date May 1, 2026).
The affected units were programmed incorrectly. When connected to the Aerin Console system, these styluses will be incorrectly recognized as RhinAer Stylus devices instead of VivAer Stylus.
The recalled devices were distributed nationwide across the following states: AL, AZ, CA, CO, GA, ID, IL, IN, KY, LA, MI, MN, NE, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV.
Healthcare facilities and individuals with VivAer Stylus units from Lot #10235 should verify the UDI (01)08886479300269(17)260501(10)10235 on their devices and contact Aerin Medical, Inc. for replacement or return instructions.
The recalled product
- Product
- Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
- Manufacturer
- Aerin Medical, Inc.
- Affected units
- 479
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 (3)
- Lot #10235
- exp. 2026-05-01
- UDI (01)08886479300269(17)260501(10)10235
Distribution
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