Bryan Medical recalls Aeris Balloon Dilation Catheter (Model KG0930) due to mislabeling. Affected units may not be safe for use. Learn if your device is recalled and what to do.
Devices were mislabeled.
Bryan Medical is recalling Aeris Balloon Dilation Catheters that were mislabeled. This could lead to incorrect use or safety issues if the device is not properly identified.
Mislabeling means the device might not be correctly identified, which could lead to improper use or incorrect medical procedures. This could cause complications if the device is not used as intended.
Healthcare professionals using the Aeris Balloon Dilation Catheter for medical procedures may be affected. Patients receiving the device could also be at risk if mislabeled.
Check for the model number KG093: If your device has this model and the lot number 1402309E, it is affected. The UDI code +B472KG09301 is also a key identifier.
Look for the model number KG0930 and lot number 1402309E on the device label.
The recall states the devices were mislabeled, but the official notice does not specify if this causes immediate danger or requires immediate action.
Check for the model number KG0930 and lot number 1402309E on the device label. The UDI code +B472KG09301 is also a key identifier.
The recall does not specify a remedy, so no action is required beyond checking if your device matches the identifiers listed.
We’ve drafted a message you can send Bryan Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2148-2023 — Bryan Medical Bryan Medical Hello, I own a Bryan Medical that is covered by recall Z-2148-2023 from Bryan Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
