Recall Z-2836-2026— INTEGRATED MEDCRAFT LLC

Name: FDA recall Z-2836-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-07

Class II · Ongoing

Class II FDA medical device recall by INTEGRATED MEDCRAFT LLC, initiated 2026-07-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Devices could potentially contain an occluded or partially occluded Guedel Airway tip..

Recalling firm: INTEGRATED MEDCRAFT LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-07-07
Firm location: East Hampton, CT, United States

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.