Aerin Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0808-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 12, 2024

Date Posted: January 15, 2025

Recall Number: Z-0808-2025

Event ID: 95832

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.

Status: Ongoing

Product Quantity: 479 units

Code Information:

Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated