Integra LifeSciences recalls MicroMyst Applicators due to lack of sterility assurance. Affected units include all lots of model 20500:500DS. Consumers should contact Integra for details.
Lack of sterility assurance.
Integra LifeSciences is recalling MicroMyst Applicators (box of 5) because they lack sterility assurance. This could lead to infections if used improperly. The recall affects all units sold.
The applicators lack sterility assurance, meaning they might not be clean enough for medical use. This could cause infections if the device is used without proper cleaning.
Users of the MicroMyst Applicator for medical liquid applications. Those with the model 205000DS are most at risk.
Check for the model number 205000DS on the applicator box. All lots of this product are affected.
Reach out to Integra LifeSciences for specific instructions on how to handle the recalled product.
The recall indicates a lack of sterility assurance, so it is not safe for medical use without proper cleaning.
Look for the model number 205000DS on the applicator box; all lots are affected.
Contact Integra LifeSciences for specific instructions on handling the recalled product.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1961-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-1961-2025 from Integra. 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.