Intersurgical recalls
Intersurgical appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2017-12-13 to 2026-08-26 |
| By agency | FDA Device (13) |
| By classification | Class II (12), Class I (1) |
| By status | terminated (8), ongoing (5) |
| Distribution named in notices | AZ, CA, CT, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MO, NJ, NV, NY, OH, PA, SC, TN, TX, US, UT, VA |
Recalls
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green
FDA Device · Class II · 2026-08-26 · Intersurgical
Reason: Devices could potentially be occluded or partially occluded. - One-Piece Guedel Airway, size 00, ISO 5.0, Blue
FDA Device · Class II · 2026-08-26 · Intersurgical
Reason: Devices could potentially be occluded or partially occluded. - One-piece Guedel airway, size 3, ISO 9.0, yellow
FDA Device · Class II · 2025-08-13 · Intersurgical
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. - One-piece Guedel airway, size 2, ISO 8.0, green
FDA Device · Class II · 2025-08-13 · Intersurgical
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. - i-view video laryngoscope
FDA Device · Class I · 2025-07-23 · Intersurgical
Reason: Potential for faulty devices as a result of depleted batteries. - Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
FDA Device · Class II · 2022-10-26 · Intersurgical
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 t… - Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems
FDA Device · Class II · 2021-01-06 · Intersurgical
Reason: The device was assembled with the incorrect exhalation port which can cause gas leakage. - Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000
FDA Device · Class II · 2020-01-15 · Intersurgical
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. - Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030
FDA Device · Class II · 2020-01-15 · Intersurgical
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. - Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031
FDA Device · Class II · 2020-01-15 · Intersurgical
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. - Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000
FDA Device · Class II · 2020-01-15 · Intersurgical
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. - Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
FDA Device · Class II · 2018-07-04 · Intersurgical
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. - Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pedia…
FDA Device · Class II · 2017-12-13 · Intersurgical
Reason: A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.