Bien-Air OSSEOSTAP Footcontrol devices with serial numbers starting 18D0006-18D0030 and 16A0005-16A0014, 17D0011, 17G0006 may have a magnet that could cause unattended motor start during ENT surgery. Recalled units need immediate action.
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Bien-Air OSSEOSTAP Footcontrol devices used in ENT surgery have a magnet that may detach and cause the device to start unexpectedly without supervision. This poses a risk of uncontrolled movement during surgery, potentially causing injury to the patient.
The magnet inside the foot pedal can become detached and cause the device to start automatically without supervision. This could lead to uncontrolled movement during surgery, potentially causing injury to the patient.
Surgical teams using the Bien-Air OSSEOSTAP Footcontrol device during ear, nose, and throat procedures are most at risk. Patients undergoing ENT surgery with this specific device model are affected.
Check for serial numbers starting with 18D0006 through 18D0030, 16A0005 through 16A0014, 17D0011, or 17G0006. The device is used during ear, nose, and throat (ENT) surgery to control surgical movements.
Discontinue use of the device if it has the recalled serial numbers listed above.
The magnet inside the foot pedal may detach and cause the device to start unexpectedly without supervision during surgery, potentially causing injury.
Serial numbers starting with 18D0006 through 18D0030, 16A0005 through 16A0014, 17D0011, or 17G0006.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Bien-Air Surgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0178-2021 — Bien-Air Surgery Bien-Air Surgery Hello, I own a Bien-Air Surgery that is covered by recall Z-0178-2021 from Bien-Air Surgery. 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.
