Recall Ledger

FORWARD Gunshot Wound Kit recall (INTEGRATED MEDCRAFT LLC)

Medical deviceClass IIOngoing

Summary: INTEGRATED MEDCRAFT LLC is recalling 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.

What is being recalled

FORWARD Gunshot Wound Kit; Model: AFT-GSW;

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of GA, VA. (states named: Georgia, Virginia)

How to tell if yours is affected

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;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-0147-2027
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedSeptember 25, 2026
ReportedOctober 21, 2026
CompanyINTEGRATED MEDCRAFT LLC
Company locationEast Hampton, CT, United States
Initiated byVoluntary: Firm initiated
Quantity1033

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