RegWardenFDA facility compliance records
Company

CARE ESSENTIALS PTY LTD

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

Recalls by year

FDA actions on record by year2020: 1 recalls20172018201912020202120222023202420252026
  • Recalls (1)

Registered facilities (3)

Recalls & enforcement

  • Class IITerminated2020-01-07
    Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.

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. “CARE ESSENTIALS PTY LTD — 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-10048196-care-essentials-pty-ltd/

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