CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
VivAer Stylus recalled by Aerin Medical
Aerin Medical is recalling Aerin Medical 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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
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
Is VivAer Stylus recalled?
Yes. Aerin Medical recalled VivAer Stylus on 12 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0808-2025.
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 21 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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