FDA-Device2026-10-14Class IIPROCESSING DEFECT
Safeguard US compression bandages recalled for potential material degradation risk
What this means
Safeguard US compression bandages used in trauma kits and first aid bags may degrade over time, potentially allowing foreign material to enter a wound. This degradation could require additional wound cleaning and may increase the risk of infection or scar tissue formation.
- Check any trauma kits, IFAK bags, or first aid kits you own for Safeguard US products listed in this recall
- Do not use affected compression bandages for wound care
- Replace recalled bandages with new stock or contact Safeguard US for a replacement
- Visit the FDA website or contact Safeguard US for the complete list of affected product lots and reference numbers
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
46,881
Manufactured in
13359 Reese Blvd E, N/A, Huntersville, NC, United States
Products
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; Medic Enhancement Set, 82-504-03; Medic Enhancement Resupply, 82-504-05; Emergency Trauma Kit, 82-520; First Responder - Intermediate, Coyote Brown, 83-303; First Responder, Intermediate, Black, 83-303-BL; DC-First Responder - Intermediate - Foliage Green, 83-303-FG; First Responder, Intermediate, Multicam, 83-303-MC; First Responder - Advanced- Coyote Brown, 83-305-CB; Combat Life Saver - Intermediate - Coyote Brown, 83-323-CB; Combat Life Saver - Intermediate - Multicam, 83-323-MC; Multi Mission, Advanced, Black - Stocked, 84-446-01-BL; Multi Mission, Advanced, Coyote Brown - Stocked, 84-446-01-CB; Multi Mission, Advanced, Multicam - Stocked, 84-446-01-MC; Direct Action Bag, Coyote Brown, Advanced, Stocked, 84-497-CB; DC-DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED, 84-497-FG; Direct Action Bag, Multicam, Advanced, Stocked, 84-497-MC; Bleeding Control Kit - Advanced, Stocked, 87-155; Stop the Bleed Kit (NJSP), 87-232; Patrol Officer IFAK - Basic, 88-105-01; Patrol Officer IFAK - Advanced, 88-105-03; High Threat Kit - Basic, 88-108-01; High Threat Kit - Intermediate, 88-108-02; High Threat Kit - Advanced, 88-108-03; High Threat Kit - PS, 88-108-05; Micro Trauma Kit (without Tourniquet), Black, 88-147; SDR EDC v1 - OTC, SDR-EDC1OTC; DC-SDR EDC v1 - OTC, SDR-EDC1-OTC; SDR Tactical Battle Belt IFAK - OTC - Black, SDR-TBBOTC; DC-SDR Tactical Battle Belt IFAK - OTC, SDR-TBB-OTC; SDR Tactical Battle Belt IFAK - OTC - Coyote Brown, SDR-TBBOTC-CB; Emergency Trauma Kit (Employee only kit), SG0999/COM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0081-2027Want us to check the next one for you?
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