RegWardenFDA facility compliance records
Company

INTERSURGICAL, INC.

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2018: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2022: 1 recalls; 2025: 2 recalls; 2026: 1 recalls12017120181201912020202112022202320242202512026
  • Recalls (8)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-06-15
    Devices could potentially be occluded or partially occluded.
  • Class IIOngoing2025-06-20
    Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
  • Class IOngoing2025-06-17
    Potential for faulty devices as a result of depleted batteries.
  • Class IITerminated2022-08-29
    Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot…
  • Class IITerminated2020-11-11
    The device was assembled with the incorrect exhalation port which can cause gas leakage.
  • Class IITerminated2019-08-07
    The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
  • Class IITerminated2018-04-25
    When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.
  • Class IITerminated2017-04-03
    A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

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. “INTERSURGICAL, 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-9002725-intersurgical-inc/

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