FDAJune 24, 2016device
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 d...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
danville materialsdanville
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMagnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-12026-03-31
- CPSCPersilux Brand Zebra Blinds Recalled Due to Strangulation and Entanglement Hazards and Risk of Serious Injury or Death; Violates Federal Rule for Window Coverings; Sold on Amazon2025-09-25
- FDABio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)2025-04-07
- CPSCNewCosplay Children's Sleepwear Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by Weihai Juanhai Decoration Material; Sold Exclusively at Amazon.com2023-01-19
- FDAGM Helix Acqua Implant 3.5x10, Article No. 140.9442021-10-11
- FDAComposiTCP 30 Interference screw D 7- L:25 mm, REF 1100046052021-10-07
- CPSCWilliams Advanced Materials & Chemicals Recalls Three Chemical Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement (Recall Alert)2021-05-27
- CPSCGorilla Commerce Recalls Oven Liners Due to Risk of Carbon Monoxide Poisoning (Recall Alert)2020-10-29
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