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U.S. Department of Health and Human Services

Class 2 Device Recall FORWARD Gunshot Wound Kit

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 Class 2 Device Recall FORWARD Gunshot Wound Kitsee related information
Date Initiated by FirmSeptember 25, 2026
Date PostedOctober 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0147-2027
Recall Event ID 99948
Product Classification First aid kit without drug - Product Code OHO
ProductFORWARD Gunshot Wound Kit; Model: AFT-GSW;
Code Information Model: ATF-GSW; UDI-DI: 00850056748063; Lot Numbers: IMC-00000024, IMC-00000034, IMC-00000053, IMC-00000056, IMC-00000076, IMC-00000081, IMC-00000082, IMC-00000083, IMC-00000084, IMC-00000085, IMC-00000094, IMC-00000148, IMC-00000149, IMC-00000152, IMC-00000153, IMC-00000154, IMC-00000173, IMC-00000174, IMC-00000179, IMC-00000186, IMC-00000187;
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		Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.
FDA Determined
Cause 2		Component change control
ActionOn September 25, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Immediately discontinue use of any product matching the affected item(s) and lot number(s) listed in the item table above. Inspect inventory for affected product. If you have no products matching the affected item(s), please fill out the acknowledge receipt form (referenced below) and indicate that you have none of these products in inventory. 2. A copy of the Urgent Medical Device Recall from Safeguard Medical has been included for reference. 3. If you have product affected by this notice, fill out the attached Acknowledgement and Receipt Form and return it to quality@integratedmc.com. To ensure timely product replacement, please respond within 30 days from date of this notice. 4. If you do not have the recalled product in stock, please check the appropriate box on the form. 5. If you have further distributed any of the items referenced in this notification, provide your customers with a copy of this notification and request that they return the affected product directly to you or directly to Integrated MedCraft.
Quantity in Commerce1033
DistributionUS Nationwide distribution in the states of GA, VA.
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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