Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aeris Balloon Dilation Catheter Recalled by Bryan Medical Inc Due to Mislabeling

Date: May 16, 2023
Company: Bryan Medical Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bryan Medical Inc directly.

Affected Products

Aeris Balloon Dilation Catheter

Quantity: 5 units

Why Was This Recalled?

Devices were mislabeled.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bryan Medical Inc

Bryan Medical Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report