Recall Z-2952-2026 ยท CAE Airway, Oropharyngeal, Anesthesiology
Intersurgical Inc
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
| Date | Aug 14, 2026 (initiated Jun 15, 2026) |
| Status | Open, Classified |
| Reason | Devices could potentially be occluded or partially occluded. |
| Root cause | Process control |
| 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. |
| Quantity | 21,269 units |
| Distribution | US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.