Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Perioscopy Sheath: Part number: 1008 Recalled by Danville Materials, Inc. Due to The Perioscopy Sheaths are currently provided with a...
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 Danville Materials, Inc. directly.
Affected Products
Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
Quantity: ~ 2123 units
Why Was This Recalled?
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
Where Was This Sold?
US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
About Danville Materials, Inc.
Danville Materials, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report