FDAMarch 9, 2015device
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Comp...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
What to do
FDA enforcement status: Terminated
Brands named
specialty appliance worksspecialtyspecialty appliance
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCSchool Specialty Recalls Tip Restraint Kits Included in Childcraft Furniture Due to Risk of Serious Injury or Death from Tip-Over Hazard2026-06-11
- CPSCFree-Standing Professional Gas Ranges Recalled Due to Risk of Burn Hazard; Manufactured by Fisher & Paykel2026-04-16
- FDAThyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-022026-01-16
- CPSCHEZI Brand Power Strips Recalled Due to Risk of Serious Injury or Death from Electrocution; Sold by HEZI HOME2026-01-15
- FDAALUMINIUM HAMMERED KADAI SIZE 7 8 901000 000057 MADE IN INDIA2025-10-31
- FDAAFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.2025-09-29
- FDAWyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.2025-09-29
- USDA FSISFSIS Issues Public Health Alert for Frozen Pork and Beef Tortellini Product Due to Misbranding and Undeclared Allergens2025-07-30
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