INTEGRATED MEDCRAFT LLC recalls FORWARD Oral Airway Kit (OPA Sizes 5
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:1000035REF Number41 affected lotsIMC-00000060IMC-00000066IMC-00000078IMC-00000086IMC-00000092IMC-00000096IMC-00000096IMC-00000097
+33 more
IMC-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 detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2836-2026
- FDA device classification · CAEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5110The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find INTEGRATED MEDCRAFT LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
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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