RegWardenFDA facility compliance records
Company

NORTH COAST MEDICAL, INC.

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

Recalls by year

FDA actions on record by year2021: 1 recalls; 2023: 1 recalls201720182019202012021202212023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-08-18
    The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
  • Class IOngoing2021-08-27
    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-…

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. “NORTH COAST 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-9000531-north-coast-medical-inc/

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