Recall Z-2836-2026 ยท CAE Airway, Oropharyngeal, Anesthesiology
INTEGRATED MEDCRAFT LLC
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
| Date | Jul 31, 2026 (initiated Jul 7, 2026) |
| Status | Open, Classified |
| Reason | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. |
| Root cause | Component design/selection |
| Action | Firm initially notified customers on June 23, 2026 via email and June 24,2026 via postal mail. Updated letters were sent on July 7, 2026 via email. Customers were instructed to immediately discontinue use of affected product and inspect inventory for affected product. Customers should return affected product to Integrated MedCraft. If the customer has further distributed affected product, they should notify customers who received the product. |
| Quantity | 509 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.