FORWARD Gunshot Wound Kit recallZ-0147-2027 · Integrated Medcraft LLC · initiated Sep 25, 2026
Open, Classified All recalls posted in October 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integrated Medcraft LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Component change control
What the company is doing
On 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 [email protected]. 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.
Recall details
- Recall number
- Z-0147-2027
- Recall class
- Not yet classified by the FDA
- Status
- Open, Classified
- Initiated by the company
- Sep 25, 2026
- Posted by the FDA
- Oct 9, 2026
- Recalling firm
- Integrated Medcraft LLC
- Quantity
- 1033
- Product code
- OHO
- Distribution
- US Nationwide distribution in the states of GA, VA.
Product description
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Code information (models, lots, serial numbers)
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;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FORWARD Gunshot Wound Kit ATF-GSWIntegrated Medcraft LLC · Dressing, Wound, Occlusive1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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