CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

Forward Gunshot Wound Kit recalled by Integrated Medcraft

Integrated Medcraft is recalling Forward Gunshot Wound Kit, distributed nationwide in the US. The recall was initiated on 25 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 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;

Quantity recalled1033

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0147-2027
FDA event ID: 99948
Recalling firm: Integrated Medcraft, East Hampton, CT
Classification: Class II
Status: Ongoing
Recall initiated: 25 Sep 2026
FDA classified: 9 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

25 Sep 2026	Recall initiated by company
9 Oct 2026	Classified by FDA	+14 days
21 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

FORWARD Gunshot Wound Kit; Model: AFT-GSW;

Where it was distributed

US Nationwide distribution in the states of GA, VA.

Nationwide Georgia Virginia

Questions about this recall

Why was it recalled?

Which lots are 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;

Where was it sold?

US Nationwide distribution in the states of GA, VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Integrated Medcraft

All 3

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Kingfisher Compact Individual First Aid Kit recalled	Integrated Medcraft	Other	Nationwide
12 Aug 2026Device	CLASS II	Forward Oral Airway Kit (OPA Sizes 5, 6.5, 7 recalled	Integrated Medcraft	Other	Nationwide

Other Other Medical Devices recalls

All 13,929

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Rapicide PA Part A High-Level Disinfectant recalled by Steris	Steris	Other	Nationwide
21 Oct 2026Device	CLASS II	NeuroStar Advanced Therapy System recalled by Neuronetics	Neuronetics	Other	Nationwide
21 Oct 2026Device	CLASS II	TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide