RegWardenFDA facility compliance records
Company

FLEXICARE MEDICAL LTD.

3 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2019: 1 recalls; 2020: 1 recalls; 2025: 1 recalls2017201812019120202021202220232024120252026
  • Recalls (3)

Registered facilities (4)

Recalls & enforcement

  • Class IOngoing2025-07-11
    Laryngoscope handles may not illuminate as intended.
  • Class ITerminated2020-09-22
    When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
  • Class IITerminated2019-11-27
    The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity whic…

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. “FLEXICARE MEDICAL 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-8021995-flexicare-medical-ltd/

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