Medtronic Xomed recalls specific Lamicel cervical dilators due to potential contamination from inadequate sterilization. Affected units have unique serial numbers; consumers should contact the company for details.
Routine sterilization dose does not meet the required Sterility Assurance Level.
Medtronic Xomed is recalling certain Lamicel cervical dilators because they may not be properly sterilized, which could lead to infections. This recall affects specific model numbers and production lots.
The dilators may not meet required sterility standards during routine sterilization, potentially allowing contaminants to remain. This could increase the risk of infection during medical procedures if the device is used without proper sterilization.
Women using the recalled Lamicel cervical dilators for medical procedures are affected. Healthcare providers and patients who have the specific model numbers listed are most at risk.
Check the product label for the model 'Lamicel 20PK 3MM INTL' and the unique serial numbers listed in the recall notice. The affected units have specific production lots from 1996 to 2023.
Look for the model number 'Lamicel 20PK 3MM INTL' and the unique serial numbers listed in the recall notice.
The Lamicel cervical dilators may not meet required sterility standards due to inadequate sterilization during routine processing.
The recall notice does not specify a remedy; contact Medtronic Xomed directly for further instructions.
Yes, the affected units have specific serial numbers listed in the recall notice, including lots from 1996 to 2023.
We’ve drafted a message you can send Medtronic Xomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0733-2020 — Medtronic Xomed Medtronic Xomed Hello, I own a Medtronic Xomed that is covered by recall Z-0733-2020 from Medtronic Xomed. 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.
