Integra LifeSciences Recalls MicroMyst Applicators Over Sterility Risks

Integra LifeSciences, a leading global medical technology company, has announced a voluntary recall of its MicroMyst Applicators due to potential concerns regarding sterility.

The recall comes after an internal review revealed incomplete bioburden assessments (tests that check for microbes before sterilization) and missing documentation in the sterilization transfer process. These lapses could compromise sterility, creating risks of infection or inflammation for patients.

About the Recall

• Product: MicroMyst® Applicator, packaged in boxes of 5.

• Catalog Number: 205000DS.

• Distribution: Worldwide – including the U.S., Canada, EU, Australia, Asia, and Latin America.

• Regulatory Action:

• FDA (U.S.): Class I recall (highest level).

• Health Canada: Type II recall.

Why This Matters

While no serious injuries have been reported so far, the potential for infection highlights the critical importance of sterilization validation in medical device manufacturing. Even minor lapses in testing or documentation can trigger major global recalls.

Action for Healthcare Providers

1. Identify and quarantine all MicroMyst® Applicator units in your inventory.

2. Complete recall acknowledgement forms and notify Integra LifeSciences.

3. Return affected units after receiving RMA (Return Material Authorization) instructions.

4. No special patient follow-up is required if products were used under standard protocol.

   Global Regulatory Notes

   • The FDA classified this as a Class I recall – the most serious category.

   • Health Canada issued a Type II recall, requiring prompt corrective actions.

   • European health authorities (HPRA, UK regulators) also issued field safety notices.

     Conclusion

     This recall emphasizes the need for robust safety protocols and complete sterilization checks in medical devices. Healthcare providers and distributors should act immediately to remove affected products from circulation, protecting both patients and medical staff.