One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
FDA device recall Z-2953-2026 · posted 2026-08-14 · Open, Classified
Recall details
- Recalling firm
- Intersurgical Inc
- Reason for recall
- Devices could potentially be occluded or partially occluded.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- CAE
- Quantity affected
- 1,575 units
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Date initiated
- 2026-06-15
- Date posted
- 2026-08-14
- Location
- East Syracuse, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.