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RecallWatchMedical Device Safety
Class IIOngoingZ-2836-2026

INTEGRATED MEDCRAFT LLC recalls FORWARD Oral Airway Kit (OPA Sizes 5

INTEGRATED MEDCRAFT LLCEast Hampton, CT, United StatesReported Aug 12, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    REF Number
    41 affected lots
    IMC-00000060IMC-00000066IMC-00000078IMC-00000086IMC-00000092IMC-00000096IMC-00000096IMC-00000097
    +33 moreIMC-00000103IMC-00000110IMC-00000125IMC-00000151IMC-00000200IMC-00000201IMC-00000204IMC-000002055.011000503212123232208193324002673240373432408819324096723241654532427064326054713260640532606850326071540003.510000353219042532213076322212833230726132317627323213053251384132517565

What the firm is doing

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.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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