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Open, Classified

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.

FDA Recall Z-2836-2026 · Posted 2026-07-31

Recalling FirmINTEGRATED MEDCRAFT LLC
Recall StatusOpen, Classified
Product CodeCAE
Date Initiated2026-07-07
Product Quantity509 units

Reason for Recall

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

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

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

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