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Z-0081-2027Class II

Safeguard US Operating LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Safeguard US Operating LLC
Product type
Device
Status
Ongoing
Report date
2026-10-14
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.
Firm state
NC
Product quantity
46,881
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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.

Product description

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 Bat

Code / lot 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),

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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →