Class II

Medical Device Recall: 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.

INTEGRATED MEDCRAFT LLC · July 7, 2026

Reason for Recall

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Product Description

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

509 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2836-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.