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Open, Classified

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

FDA Recall Z-2953-2026 · Posted 2026-08-14

Recalling FirmIntersurgical Inc
Recall StatusOpen, Classified
Product CodeCAE
Date Initiated2026-06-15
Product Quantity1,575 units

Reason for Recall

Devices could potentially be occluded or partially occluded.

Firm Action

An URGENT MEDICAL DEVICE RECALL notification dated 6/12/26 was mailed and to consignees. The notification instructs consignees to immediately discontinue use of affected devices and quarantine any stock remaining. If product has been further distributed a copy of the recall notification is to be forwarded and collect their affected product. To coordinate return of goods contact Intersurgical Customer Support at 800-828-9633 from Monday through Thursday, 8:00 AM to 3:00 PM EST, and follow the provided instructions.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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