CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
VivAer Stylus recalled by Aerin Medical
Aerin Medical is recalling VivAer Stylus, distributed nationwide in the US. The recall was initiated on 12 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0808-2025
- FDA event ID
- 95832
- Recalling firm
- Aerin Medical, Sunnyvale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Nov 2024
- FDA classified
- 6 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Nov 2024 | Recall initiated by company | |
| 6 Jan 2025 | Classified by FDA | +55 days |
| 15 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
Product as listed by the FDA
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Where it was distributed
US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV.
Nationwide AlabamaArizonaCaliforniaColoradoGeorgiaIdahoIllinoisIndianaKentuckyLouisianaMichiganMinnesotaNebraskaNew YorkOhioPennsylvaniaSouth CarolinaTennesseeTexasUtah
Questions about this recall
Why was it recalled?
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
Which lots are affected?
Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235
Where was it sold?
US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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