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Intersurgical Inc FDA Recalls

6 recalls on file across devices, 1 of them Class I and 5 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.Class IIJun 15, 2026Devices could potentially be occluded or partially occluded.
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.Class IIJun 15, 2026Devices could potentially be occluded or partially occluded.
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.Class IIJun 20, 2025Potential contamination with small burrs, which if detach co
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.Class IIJun 20, 2025Potential contamination with small burrs, which if detach co
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscClass IJun 17, 2025Potential for faulty devices as a result of depleted batteri
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000Class IIAug 29, 2022Printing error on the device, size 3 Solus Standard laryngea

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