Recall Z-2148-2023— Bryan Medical Inc

Name: FDA recall Z-2148-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-16

Class II · Ongoing

Class II FDA medical device recall by Bryan Medical Inc, initiated 2023-05-16. It names one FDA 510(k) clearance: K150951. Product: Aeris Balloon Dilation Catheter. Reason: Devices were mislabeled..

Recalling firm: Bryan Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-05-16
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K150951 — aeris Balloon Dialation CatheterBryan Medical, Inc.·cleared 2015-06-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Aeris Balloon Dilation Catheter

Reason for recall

Devices were mislabeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.