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U.S. Department of Health and Human Services

Class 2 Device Recall Kingfisher Compact Individual First Aid Kit

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 Class 2 Device Recall Kingfisher Compact Individual First Aid Kitsee related information
Date Initiated by FirmJuly 07, 2026
Date PostedJuly 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2837-2026
Recall Event ID 99295
Product Classification First aid kit without drug - Product Code OHO
ProductKingfisher 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.
Code Information Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Lot Numbers: IMC-00000132, IMC-00000139. Containing the affected One-piece Guedel airway components 1. Size 00, 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, 32513841, 32517565
FEI Number 3030078769
Recalling Firm/
Manufacturer		 INTEGRATED MEDCRAFT LLC
1 Sinco Pl Unit A10
East Hampton CT 06424-2129
For Additional Information Contact
860-836-4692
Manufacturer Reason
for Recall		Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
FDA Determined
Cause 2		Component design/selection
ActionFirm 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.
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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