Agency classClass IIOur severity:High FDA (Devices)·Z-2836-2026·Announced 2026-08-12

FORWARD Oral Airway Kit Recall for Potential Airway Obstruction

Integrated Medcraft LLC recalls FORWARD Oral Airway Kits due to potential occlusion of the airway tip, which could impede breathing in medical settings.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a risk-of-harm medical device where injury has not yet been reported. The occluded airway tip could cause breathing difficulties but no hospitalizations or injuries have been documented.

Plain-English summary

The U.S. Food and Drug Administration is recalling approximately 509 FORWARD Oral Airway Kits manufactured by Integrated Medcraft LLC. The kits contain oral airway components that may have an occluded or partially occluded Guedel Airway tip, which could impede proper ventilation during medical procedures.

This recall affects OPA Sizes 5, 6.5, 7, 8, 9, 10, 12 and includes specific lot numbers distributed nationwide in the United States. The oral airway is a medical device used by healthcare providers to maintain airway patency during procedures or emergencies when normal breathing is compromised.

Healthcare providers should immediately stop using the affected kits and return them to the manufacturer. No injuries or illnesses have been reported in connection with this recall. Consumers should contact their healthcare provider or the manufacturer with questions.

The recalled product

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.
Manufacturer: INTEGRATED MEDCRAFT LLC
Category: Medical Device — Oral Airway Device
Hazard: airway-obstruction
breathing-difficulty
Affected units: 509

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

FORWARD Oral Airway Kit (OPA Sizes 5
6.5
7
8
9
10
12). REF Number: 1011-40002. Lot Numbers: IMC-00000060
IMC-00000066
IMC-00000078
IMC-00000086
IMC-00000092
IMC-00000096
IMC-00000097
IMC-00000103
IMC-00000110
IMC-00000125
IMC-00000151
IMC-00000200
IMC-00000201
IMC-00000204

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by INTEGRATED MEDCRAFT LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · INTEGRATED MEDCRAFT LLC

See all →

High
Integrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12

Same hazard · airway obstruction