Oto Med recalls S-3500 bone dust collectors with holes in sterile pouches that could cause infection during surgery. Affected units have specific lot numbers and were sold in 2006-2007. Stop using immediately to prevent infection risks.
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Oto Med is recalling bone dust collectors used in ear surgery that have holes in their sterile packaging. This could allow bacteria to enter the surgical site, increasing infection risk during procedures.
The sterile Tyvek pouches that hold the bone dust collectors developed holes during testing. If these holes are present, bacteria could enter the surgical site during procedures, increasing infection risk.
Surgical staff and hospitals that purchased the S-3500 bone dust collectors with specific lot numbers between 2006 and 2007. Those using the devices for ear surgery are most at risk.
Check for the model S-3500 with lot numbers listed: 019120G(2), 029119G(2), 039118G(2), 049119G(2), 0712119G(2), 0812118G(2), 0912118G(2), 1012119G(2), 1212118G(2), or 200602. These units were sold between 2006 and 2007.
Discontinue use of the S-3500 bone dust collectors with the listed lot numbers to prevent potential infection during surgery.
During internal testing, holes were found in the sterile Tyvek pouches of the devices, which could allow bacteria to enter the surgical site.
Stop using the device immediately and contact Oto Med for instructions on how to return it.
Yes, check for lot numbers: 019120G(2), 029119G(2), 039118G(2), 049119G(2), 0712119G(2), 0812118G(2), 0912118G(2), 1012119G(2), 1212118G(2), or 200602.
We’ve drafted a message you can send Oto Med to request your refund or repair — edit it as you like.
Subject: Recall Z-1520-2021 — Oto Med Oto Med Hello, I own a Oto Med that is covered by recall Z-1520-2021 from Oto Med. 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.
