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Open, Classified

Aeris Balloon Dilation Catheter

FDA Recall Z-2148-2023 · Posted 2023-07-17

Recalling FirmBryan Medical Inc
Recall StatusOpen, Classified
Product CodeKTI
Date Initiated2023-05-16
Product Quantity5 units

Reason for Recall

Devices were mislabeled.

Firm Action

Customers were emailed a recall notification dated 5/16/2023 requesting the return of affected devices. Customers were asked to quarantine all affected devices, complete the attached Recall Notification Confirmation Form, and return the form to the individuals identified in the notice.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide distribution in the states of GA, NY, & PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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