# Class II recall Z-0147-2027: INTEGRATED MEDCRAFT LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0147-2027 |
| Recalling firm | INTEGRATED MEDCRAFT LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 1033 |
| Distribution | US Nationwide distribution in the states of GA, VA. |
| Recall initiated | 2026-09-25 |
| Reported | 2026-10-21 |
| Firm location | East Hampton, CT, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0147-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.