RegWardenFDA facility compliance records
Facility

AirLife Finland Oy

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

Activity by year

FDA actions on record by year2016: 1 inspections; 2022: 2 recalls; 2023: 1 recalls; 2025: 3 recalls120162017201820192020202122022120232024320252026
  • Recalls (6)
  • Inspections (1)

Devices registered here (1)

  • Electrode, Circular (Spiral), Scalp And Applicator
    Product code HGP (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.2675

Recalls & enforcement

  • Class IOngoing2025-12-15
    Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
  • Class IOngoing2025-05-15
    The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant h…
  • Class IOngoing2025-05-01
    Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequence…
  • Class IIOngoing2023-10-11
    A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
  • Class IIOngoing2022-12-22
    There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
  • Class IITerminated2022-09-08
    The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

FDA inspections (1)

  • NAI2016-09-29
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AirLife Finland Oy (FEI 3010838917) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010838917-airlife-finland-oy/

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