# Class II recall Z-0081-2027: Safeguard US Operating LLC

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0081-2027 |
| Recalling firm | Safeguard US Operating LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Battle Bandage, REF: 32-700;  Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL;  Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC;  Patrol IFAK II, Olive Drab, Stocked (Option 1),  81-129-OD;  IFAK Bag, Intermediate, Black - Stocked, 81-133-BL;  IFAK Bag, Intermediate, Coyote Brown - Stocked, 81-133-CB;  IFAK Bag, Intermediate, Multicam - Stocked, 81-133-MC;  IFAK Bag, Advanced, Black - Stocked, 81-135-BL;  IFAK Bag, Advanced, Multicam - Stocked, 81-135-MC;  LEO Patrol Kit, 81-139;  IFAK Refill, 81-301;  IFAK Resupply, 81-303-01;  IFAK Resupply - CS/30, 81-303-30;  K9 Trauma Kit, 81-605;  |
| Reason | Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection. |
| Quantity | 46,881 |
| Distribution | Worldwide - US Nationwide distribution including in the states of FL, OK, CA, WA, GA, TX, PA, IL, MD, NC, OR, DE, NJ, MI, RI, AR, WI, AZ, CO, IN, MO, OH, MA, NY, VA, KY, UT, NM, SC, TN, LA, AL, MN, MT, AK, WV, KS, NE, WY, MS, HI, NH, IA, DC, CT and the countries of BRA, BEL, SGP, AUS. |
| Recall initiated | 2026-09-02 |
| Reported | 2026-10-14 |
| Firm location | Huntersville, NC, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 21 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-0081-2027%22). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.