Device recall

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

FDA recall source

Recall number

Z-0081-2027

Event id

99814

Status

Ongoing

FDA classification

Class II

Recalling firm

Safeguard US Operating LLC

Report date

Oct 14, 2026

Posted

Oct 2, 2026

Initiated

Sep 2, 2026

Center classification date

Oct 2, 2026

Product code

MHW

Device type

Dressing, Compression

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.

Root cause

Component change control

Quantity

46,881

Code info

REF/UDI-DI/Lot(Expiration): 32-700/M68932700070/PBO0005447(10/31/2029), PBO0006353(2/12/2030), PBO0004168(9/12/2029), PBO0006219(10/22/2029), PBO0005499(12/27/2028), PBO0005960(11/29/2029), PBO0004076(9/12/2029), PBO0004497(10/31/2029), PBO0004261(9/12/2029), PBO0004301(10/17/2029), PBO0005856(11/29/2029), PBO0005599(2/12/2030), PBO0006434(12/25/2029), PBO0009032(8/14/2031), PBO0008804(9/13/2030), PBO0010083(12/4/2031), PBO0010114(1/14/2032), PBO0007376(6/20/2030), PBO0005601(1/18/2030), PBO0007651(10/31/2029), PBO0007809(7/29/2030), PBO0008889(5/7/2030), PBO0010280(8/24/2031), PBO0010523(2/9/2032), PBO0010613(2/16/2032), PBO0007921(5/7/2030), PBO0009049(8/14/2031), PBO0008482(5/7/2030), PBO0009934(12/4/2031), PBO0009717(7/29/2030), PBO0008104(6/6/2030), PBO0006035(6/6/2030), PBO0009729(8/24/2031), PBO0008615(6/6/2030), PBO0008079(5/7/2030), PBO0008184(7/29/2030), PBO0009639(8/14/2031), PBO0009858(8/24/2031), PBO0004824(12/6/2029), PBO0008078(8/25/2030); 81-125-BL/M68981125030/PBO0010399(1/9/2029), PBO0006315(7/23/2029); 81-125-MC/M68981125030/PBO0006046(12/25/2028), PBO0006198(12/25/2028), PBO0007487(11/14/2028), PBO0007765(10/10/2027), PBO0008917(1/8/2029), PBO0010390(1/9/2029); 81-129-OD/M68981129060/PBO0010400(10/18/2029), PBO0010557(1/9/2029); 81-133-BL/M68981133080/PBO0004848 (9/5/2029); 81-133-CB/M68981133080/PBO0004849(9/11/2028); 81-133-MC/M68981133080/PBO0004850(9/11/2028); 81-135-BL/M68981135060/PBO0006810(1/23/2028), PBO0008450(12/31/2028); 81-135-MC/M68981135060/PBO0008217(12/31/2028), PBO0005853(5/9/2029), PBO0008944(11/28/2029); 81-139/M68981139010/PBO0005528(11/23/2027), PBO0010122(11/23/2027), PBO0007389(11/23/2027); 81-301/M68981301030/PBO0008729(1/8/2029), PBO0009012(1/8/2029), PBO0009785(1/9/2029), PBO0008634(1/8/2029); 81-303-01/M6898130301130/PBO0006031(1/23/2028), PBO0005527(10/3/2028), PBO0007324(1/23/2028), PBO0005163(12/31/2026), PBO0004331(7/17/2028), PBO0009143(12/31/2028), PBO0006564(1/23/2028), PBO0006871(1/23/2028), PBO0005598(11/28/2028), PBO0009321(12/31/2028), PBO0009438(12/31/2028), PBO0009417(9/25/2029), PBO0008167(12/31/2028), PBO0009959(9/25/2029), PBO0005343(9/11/2028), PBO0004484(8/14/2028), PBO0004620(8/14/2028), PBO0004672(8/14/2028), PBO0009328(2/8/2030), PBO0009607(9/25/2029), PBO0007584(12/31/2028), PBO0008805(12/31/2028), PBO0009258(12/31/2028), PBO0009286(11/28/2029), PBO0006327(1/23/2028), PBO0010076(9/25/2029), PBO0007790(12/31/2028), PBO0007810(12/31/2028), PBO0007890(12/31/2028), PBO0006841(1/23/2028), PBO0007937(12/31/2028), PBO0008111(12/31/2028), PBO0007628(12/31/2028), PBO0005321(9/11/2028), PBO0006493(1/23/2028), PBO0008992(11/28/2029), PBO0009051(12/31/2028), PBO0010410(9/25/2029), PBO0006908(1/23/2028), PBO0007234(1/23/2028), PBO0007272(1/23/2028), PBO0010508(9/25/2029), PBO0010580(9/25/2029), PBO0005838(12/25/2028), PBO0005885(5/28/2029), PBO0010009(9/25/2029), PBO0005597(11/28/2028), PBO0005508(10/3/2028), PBO0009296(12/31/2028), PBO0006165(1/23/2028), PBO0006010(1/23/2028), PBO0008084(12/31/2028); 81-303-30/M6898130330010/PBO0006441(1/23/2028), PBO0006326(1/23/2028), PBO0009138(12/31/2028), PBO0009293(12/31/2028), PBO0010158(9/25/2029), PBO0008112(12/31/2028), PBO0008085(12/31/2028), PBO0008072(12/31/2028), PBO0009165(12/31/2028), PBO0009832(9/25/2029), PBO0008439(12/31/2028), PBO0006599(1/23/2028), PBO0008836(12/31/2028), PBO0009329(2/8/2030), PBO0009685(9/25/2029), PBO0004465(8/14/2028), PBO0005391(10/3/2028), PBO0005394(10/3/2028), PBO0005681(10/3/2028), PBO0005750(12/27/2028), PBO0006001(5/28/2029), PBO0006581(1/23/2028), PBO0006649(1/23/2028), PBO0006736(1/23/2028), PBO0006822(1/23/2028), PBO0006872(1/23/2028), PBO0007106(1/23/2028), PBO0007251(1/23/2028), PBO0008825(12/31/2028), PBO0009022(11/28/2029), PBO0008872(12/31/2028), PBO0009740(9/25/2029), PBO0009782(9/25/2029), PBO0009768(9/25/2029), PBO0009831(9/25/2029), PBO0009937(12/31/2028), PBO0009918(9/25/2029), PBO0009951(9/25/2029), PBO0010073(9/25/2029), PBO0010097(9/25/2029), PBO0008957(12/31/2028), PBO0009958(9/25/2029), PBO0009642(9/25/2029), PBO0009664(9/25/2029), PBO0007597(1/23/2028), PBO0007627(12/31/2028), PBO0007988(12/31/2028), PBO0004412(1/20/2028), PBO0004125(12/31/2026), PBO0005322(11/19/2028), PBO0005887(12/27/2028), PBO0006066(1/23/2028), PBO0006117(12/25/2028), PBO0006011(5/28/2029), PBO0004673(8/14/2028), PBO0005169(12/31/2026), PBO0006139(1/23/2028), PBO0006116(5/28/2029), PBO0006227(1/23/2028), PBO0006272(1/23/2028), PBO0006273(1/23/2028), PBO0006191(1/23/2028), PBO0006339(1/23/2028), PBO0010746(9/25/2029), PBO0004359(12/31/2026), PBO0006379(1/23/2028), PBO0004737(7/17/2028), PBO0005576(10/3/2028), PBO0005680(11/28/2028), PBO0006777(1/23/2028), PBO0006669(1/23/2028); 81-605/M68981605020/PBO0005156(12/31/2026), PBO0006811(10/31/2027), PBO0008219(10/31/2027), PBO0004893(10/31/2025), PBO0009367(10/31/2027), PBO0008464(10/31/2027); 82-504-03/M6898250403050/PBO0006956(11/30/2025); 82-504-05/M6898250405060/PBO0006957(11/30/2025), PBO0008338(3/30/2026), PBO0006430(11/30/2025), PBO0010030(2/25/2028), PBO0005728(7/31/2026), PBO0008997(6/30/2026), PBO0005924(7/31/2026); 82-520/M68982520020/PBO0008664(10/29/2028), PBO0008767(12/31/2028); 83-303/M68983303040/PBO0009194(5/7/2030), PBO0010271(9/25/2029), PBO0005157(12/31/2026); 83-303-BL/M68983303040/PBO0004789(8/14/2028); 83-303-FG/M68983303040/PBO0004790(8/14/2028); 83-303-MC/M68983303040/PBO0007112(1/23/2028), PBO0008988(11/28/2029); 83-305-CB/M68983305040/PBO0004851(9/5/2029); 83-323-CB/M68983323100/PBO0004523(3/4/2024); 83-323-MC/M68983323100/PBO0004454(8/14/2028); 84-446-01-BL/M6898444601190, PBO0006368(4/3/2025), PBO0010159(2/18/2028), PBO0006836(6/13/2025), PBO0005726(5/31/2025), PBO0007075(11/30/2025), PBO0004998(10/31/2024); 84-446-01-CB/M6898444601190/PBO0005727(5/31/2025), PBO0007252(11/30/2025), PBO0009313(2/25/2028), PBO0010246(2/18/2028), PBO0008940(3/30/2026), PBO000642994/3/2025), PBO0004996(10/31/2024), PBO0006462(6/13/2025), PBO0006711(5/31/2025), PBO0008339(1/30/2026), PBO0007070(11/30/2025); 84-446-01-MC/M6898444601190/PBO0005202(10/31/2024), PBO0008340(1/30/2026), PBO0007071(11/30/2025), PBO0006428(4/3/2025), PBO0004997(10/31/2024), PBO0008423(1/30/2026), PBO0009303(2/25/2028), PBO0009314(2/25/2028), PBO0009719(2/18/2028), PBO0010160(2/18/2028), PBO0010493(2/25/2028); 84-497-CB/M68984497110/PBO0005812(4/30/2026); 84-497-FG/M68984497110/PBO0004990(10/31/2024); 84-497-MC/M68984497110/PBO0006832(11/30/2025), PBO0008367(3/30/2026); 87-155/M68987155030/PBO0004364(8/14/2028); 87-232/M68987232010/PBO0005412(8/31/2027), PBO0006639(12/31/2027); 88-105-01/M6898810501020/PBO0008466(5/7/2033); 88-105-03/M6898810503070/PBO0005280(11/1/2028), PBO0005908(12/25/2029), PBO0005998(2/12/2030), PBO0008259(10/18/2029); 88-108-01/M6898810801030/PBO0009562(11/23/2027); 88-108-02/M6898810802030/PBO0006951(11/23/2027), PBO0005757(11/23/2027), PBO0008782(11/23/2027), PBO0007373(11/23/2027); 88-108-03/M6898810803030/PBO0004612(11/23/2027), PBO0004942(11/23/2027), PBO0004525 (11/23/2027); 88-108-05/M6898810805010/PBO0006203(1/23/2028); 88-147/¿M68988147010/PBO0005267(11/23/2027), PBO0005095(11/23/2027), PBO0005937(11/23/2027), PBO0006812(11/23/2027); SDR-EDC1OTC/M689SDREDC1OCT010/PBO0005185(5/16/2027), PBO0005872(5/16/2027); SDR-EDC1-OTC/M689SDREDC1OTC050/PBO0004353(10/4/2026), PBO0004463(10/4/2026), PBO0004796(5/16/2027), PBO0004719(5/16/2027), PBO0004916(4/20/2027); SDR-TBBOTC/M6898SDRTBB0TC020/PBO0005184(8/9/2027), PBO0005754(5/16/2027); SDR-TBB-OTC/M689SDR-TBB-OTC/PBO0004797(5/16/2027), PBO0004718(5/16/2027), PBO0004915(5/16/2027); SDR-TBBOTC-CB/M689SDR-TBB-OTC/PBO0005873(5/16/2027); SG0999/COM/M689SG0999COM040/PBO0005076(12/31/2026), M689SG0999COM041/PBO0005331(8/9/2027), M689SG0999COM042/PBO0009635(8/9/2027), M689SG0999COM043/PBO0007404(8/9/2027), M689SG0999COM044/PBO0007568(8/9/2027), M689SG0999COM045/PBO0007899(8/9/2027), M689SG0999COM046/PBO0007897(8/9/2027), M689SG0999COM047/PBO0005744(5/16/2027), M689SG0999COM048/PBO0005777(5/16/2027),

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.

Voluntary or mandated

Voluntary: Firm initiated

Location

Huntersville, NC, United States