East Syracuse, NY, United States
Intersurgical Inc recalls
7 recalls recorded since 2018, most recently on 15 June 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)3
Terminated or completed4
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 15 June 2026
- Reason
- Devices could potentially be occluded or partially occluded.
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2953-2026, Z-2952-2026
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Ongoing Class II Medical devices
- Recall started
- 20 June 2025
- Reason
- 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.
- Distribution
- US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2275-2025, Z-2276-2025
- One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
- One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Ongoing Class I Medical devices
- Recall started
- 17 June 2025
- Reason
- Potential for faulty devices as a result of depleted batteries.
- Distribution
- US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2102-2025
- i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Terminated Class II Medical devices
- Recall started
- 29 August 2022
- Terminated
- 19 October 2023
- Reason
- 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 balloon) may pose health risk to the patient
- Distribution
- OH, TN, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0096-2023
- Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Terminated Class II Medical devices
- Recall started
- 11 November 2020
- Terminated
- 9 August 2022
- Reason
- The device was assembled with the incorrect exhalation port which can cause gas leakage.
- Distribution
- All of the devices were shipped to the same distributor (McKesson).
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0753-2021
- Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient
Terminated Class II Medical devices
- Recall started
- 7 August 2019
- Terminated
- 15 December 2020
- Reason
- 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.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0786-2020, Z-0784-2020, Z-0785-2020, Z-0787-2020
- Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
- Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
- Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
- Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Terminated Class II Medical devices
- Recall started
- 25 April 2018
- Terminated
- 9 April 2019
- Reason
- 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.
- Distribution
- Distributors in IL, NJ, NV, TX, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2302-2018
- Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.