Agency classClass IIOur severity:High FDA (Devices)·Z-2837-2026·Announced 2026-08-12

Integrated Medcraft Recalls First Aid Kits with Defective Airway Tips

Integrated Medcraft is recalling specific Kingfisher Compact Individual First Aid Kits because the included Guedel airway components may have occluded tips.

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: The recall is classified as FDA Class II, and the hazard involves a potential failure of a life-support device (airway occlusion) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Integrated Medcraft LLC is recalling specific Kingfisher Compact Individual First Aid Kits (REF Number: 76656) distributed nationwide in the United States. The recall involves kits containing specific One-piece Guedel airway components: Size 00 (ISO 5.0, blue, Product Code: 1100050) and Size 000 (ISO 3.5, light green, Product Code: 1000035).

The recall is being issued because the devices could potentially contain an occluded or partially occluded Guedel Airway tip. This defect may prevent the airway from functioning as intended during emergency medical procedures.

Consumers should check their first aid kits for the specific lot numbers and product codes listed in the official recall notice. If the affected components are present, users should stop using them and contact Integrated Medcraft LLC for instructions on return or replacement.

The recalled product

Product: Kingfisher Compact Individual First Aid Kit. REF Number: 76656. 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 — Airway Management
Hazard: device-malfunction
airway-occlusion

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)

ISO 5.0
blue. Product Code: 1100050. Lot Numbers: 32121232
32208193
32400267
32403734
32408819
32409672
32416545
32427064
32605471
32606405
32606850
32607154. 2. Size 000
ISO 3.5
light green. Product Code: 1000035. Lot Numbers: 32190425
32213076
32221283
32307261
32317627
32321305

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 →

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FDA (Devices) · 2026-08-12

Same hazard · device malfunction