Z-0808-2025Class II

Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile

Name: Z-0808-2025 Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile
Creator: Aerin Medical, Inc.
Published: 2024-11-12
License: https://open.fda.gov/license/

Aerin Medical, Inc. / initiated 2024-11-12 / Open, Classified / root cause: manufacturing process

FDA source

Aerin Medical, Inc. began a recall of Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile on 2024-11-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0808-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-12
Posted: 2025-01-06
Recalling firm: Aerin Medical, Inc.
Product: Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The recalling firm issued emails on 11/12/2024. It was necessary to notify several consignees by mail with an "URGENT: MEDICAL DEVICE FIELD NOTICE" letter dated 11/20/2024. The email described the product purchased by the consignee and the reason for recall. The consignee is informed the programmed treatment time will be shorter than the recommended 30 second treatment time for VivAer and the use of the device may result in insufficient treatment. Under the heading "Action to be Taken," it says if a defective device is identified or the consignee wishes to return unused devices within this production lot, they are to return them to the recalling firm, and return instructions are provided. Regarding the mailed "URGENT: MEDICAL DEVICE FIELD NOTICE" letters dated 11/20/2024, they informed the consignee that some of the units in the production lot were programmed incorrectly and, in these cases, the programmed treatment time will be 12 seconds of radiofrequency energy delivery with no cooling time, not the 30 second treatment time for VivAer that includes 18 seconds of energy delivery and 12 seconds of cooling time. The letter also contains instructions to share this notification with all device users within their facility and network to ensure they are aware of this issue. This notification should also be shared with any organization where the potentially affected devices have been transferred. If you need any further information or support concerning this notification, please contact us at [email protected] or call 512-221-9956.
Quantity in commerce: 479 units
Distribution: 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.
Product codes and lots: Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0808-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0808-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-06

Product code GEI

K200300Class IIVivAer StylusAerin Medical, Inc. / cleared 2020-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)