Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag...
FDA Device Recall #Z-0081-2027 - Class II, September 2, 2026
Recall Summary
| Recall Number | Z-0081-2027 |
| Classification | Class II - Moderate risk |
| Date Initiated | September 2, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Safeguard US Operating LLC |
| Location | Huntersville, NC |
| Product Type | Devices |
| Quantity | 46,881 |
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 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
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.
Distribution Pattern
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.
Lot / Code Information
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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| Z-3183-2024 | Class II | Kits of Convenience containing 1 of the 2 Item ... | Aug 27, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.