RegWardenFDA facility compliance records
Company

Zoe Medical, Inc

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2024: 1 recalls1’12’13’14’15’16’17’18’19’20’21’22’231’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-08-13
    This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
  • Class IITerminated2012-06-06
    Unit fails to power up, resulting in an equipment alarm

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Zoe Medical, Inc — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9041242-zoe-medical-inc/

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