RegWardenFDA facility compliance records
Company

SunMed Group Holdings, LLC dba AirLife

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

Recalls by year

FDA actions on record by year2022: 2 recalls; 2023: 1 recalls; 2025: 3 recalls2017201820192020202122022120232024320252026
  • Recalls (6)

Registered facilities (7)

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.

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. “SunMed Group Holdings, LLC dba AirLife — 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-10044795-sunmed-group-holdings-llc-dba-airlife/

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