FDADecember 5, 2022device
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
What to do
FDA enforcement status: Completed
Brands named
align technologyalign
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCJunpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries; Sold on Amazon by JSNJ_Tech Store2026-07-02
- CPSCCombination Smoke and Carbon Monoxide (CO) Detectors Recalled Due to Risk of Serious Injury or Death from Failure to Alert Consumers to Fire; Sold Exclusively on Amazon.com by Treatlife Technology2026-06-25
- CPSCLuminous Fidget Spinner Balls Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Anzmtosn2026-05-28
- CPSCSuperbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Remy&shop2026-05-14
- CPSCTiyol Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Sold on Amazon by ZW Creations2026-05-14
- CPSCLithium Coin Batteries Recalled Due?to Risk of Serious Injury or Death from Battery Ingestion; Violates Federal Statute for Child-Resistant Packaging of Coin Batteries; Imported and Sold on Amazon by LiCB2026-05-14
- CPSCEarthtec Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Tonyidea2026-04-30
- CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online2026-04-30
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