Integrated Medcraft Llc: Forward Gunshot Wound Kit; Model: Aft-gsw
Recall Summary INTEGRATED MEDCRAFT LLC is recalling the FORWARD Gunshot Wound Kit (Model AFT-GSW) because internal testing found that the sterile pad inside can degrade over time, potentially leaving fragments of nonwoven material on or near a wound. The kits were distributed nationwide, with direct distribution in Georgia and Virginia. This is a Class II recall, meaning the defect could cause serious health effects but is not immediately life-threatening.
- Recalling firm
- INTEGRATED MEDCRAFT LLC
- Product
- FORWARD Gunshot Wound Kit; Model: AFT-GSW;
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-25
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of GA, VA.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/8e0e39e0-48b7-490c-b84a-cdb6bd8c6f27