RegWardenFDA facility compliance records
Company

NORTH AMERICAN RESCUE, LLC.

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

Recalls by year

FDA actions on record by year2020: 1 recalls; 2021: 1 recalls; 2025: 1 recalls; 2026: 1 recalls20172018201912020120212022202320241202512026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2026-03-27
    Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is …
  • Class IIOngoing2025-07-01
    Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
  • Class IITerminated2021-08-27
    The device includes the incorrect Instructions for Use.
  • Class IITerminated2020-08-21
    Lack of sterility assurance of the 30-0171

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 AMERICAN RESCUE, LLC. — 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-9070484-north-american-rescue-llc/

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