RegWardenFDA facility compliance records
Company

LAERDAL MEDICAL A/S

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

Recalls by year

FDA actions on record by year2017: 2 recalls; 2020: 1 recalls; 2026: 1 recalls2201720182019120202021202220232024202512026
  • Recalls (4)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2026-01-13
    units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
  • Class IITerminated2020-12-18
    Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the us…
  • Class IITerminated2017-08-31
    A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
  • Class IITerminated2017-01-08
    The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.

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. “LAERDAL MEDICAL A/S — 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-9038993-laerdal-medical-a-s/

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