Oto Med recalls Grace Medical S-2500 bone dust collectors with holes in sterile pouches that could allow infection during surgery. Affected units have specific lot numbers. 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 Grace Medical S-2500 bone dust collectors because internal testing found holes in the sterile pouches. This could allow bacteria to enter the surgical site during procedures, risking infection for patients.
The sterile Tyvek pouches that hold bone particles during ear surgery have holes in them. This could let bacteria enter the surgical site, increasing infection risk for patients during procedures.
Surgical staff and hospitals using the Grace Medical S-2500 bone dust collectors with specific lot numbers are most at risk. Patients undergoing ear surgery with this device could face infection if the pouches are compromised.
Check for the model 'S-2500' and lot numbers: 019120G(2), 029119G(2), 039118G(2), 049119G(2), 0712119G(2), 0812118G(2), 0912118G(2), 1012119G(2), 1212118G(2), 200401.
Inspect the sterile Tyvek pouch for holes before use. If holes are present, do not use the device.
Internal testing found holes in the sterile Tyvek pouches of the devices, which could allow bacteria to enter the surgical site during procedures.
Check the lot numbers listed in the recall notice. If you have the affected lot numbers, stop using the device immediately and contact Oto Med for instructions.
The recall notice does not mention a fix or remedy. Affected units must be stopped from use until a replacement or repair is provided.
We’ve drafted a message you can send Oto Med to request your refund or repair — edit it as you like.
Subject: Recall Z-1519-2021 — Oto Med Oto Med Hello, I own a Oto Med that is covered by recall Z-1519-2021 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.
