FDAJune 20, 2025device
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
intersurgical
UPCs
050302670406985030267050659
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOne-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.2025-06-20
- FDAi-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.2025-06-17
- FDAIntersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 80030002022-08-29
- FDASmoothbore 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 during anesthesia. It provides both an inhalation and exhalation route and ma...2020-11-11
- FDASuperset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.2019-08-07
- FDASuperset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.2019-08-07
- FDADouble Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.2019-08-07
- FDADouble Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.2019-08-07
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