RecallRadar

FDA Device recall Z-0147-2027

FORWARD Gunshot Wound Kit

On 2026-10-21 the FDA classified a Class II recall of FORWARD Gunshot Wound Kit by Integrated Medcraft, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0147-2027
ClassificationClass II
Statusongoing
Initiated2026-09-25
Published2026-10-21
Last updated2026-10-27 05:30 UTC
CompanyIntegrated Medcraft
DistributionUS

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.

Identifiers

code_info
Model: ATF-GSW; UDI-DI: 00850056748063; Lot Numbers: IMC-00000024, IMC-00000034, IMC-00000053, IMC-00000056, IMC-000000…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;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.

Other recalls by Integrated Medcraft

All Integrated Medcraft recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0147-2027%22

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