Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Lamicel 20PK 3MM INTL Cervical dilator Recalled by Medtronic Xomed, Inc. Due to Routine sterilization dose does not meet the required...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Xomed, Inc. directly.
Affected Products
Lamicel 20PK 3MM INTL Cervical dilator
Quantity: 29320 units
Why Was This Recalled?
Routine sterilization dose does not meet the required Sterility Assurance Level.
Where Was This Sold?
Affected product was only distributed in Japan.
About Medtronic Xomed, Inc.
Medtronic Xomed, Inc. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report