RegWardenFDA facility compliance records
Facility

SINO-VISTA DENTAL INSTRUMENTS CO., LTD.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2019: 1 recalls; 2026: 1 recalls201720181201920202021202220232024202512026
  • Recalls (2)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2026-05-27
    Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of…
  • Class IITerminated2019-06-27
    The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the blea…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SINO-VISTA DENTAL INSTRUMENTS CO., LTD. (FEI 3006608997) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006608997-sino-vista-dental-instruments-co-ltd/

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