INTERSURGICAL, INC.

Recalls by year

Registered facilities (1)

• INTERSURGICAL, INC. FEI 1000120301 · NY

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.