CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

Battle Bandage recalled by Safeguard US Operating

Safeguard US Operating is recalling Battle Bandage, distributed nationwide in the US. The recall was initiated on 2 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/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),

Quantity recalled46,881

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0081-2027
FDA event ID: 99814
Recalling firm: Safeguard US Operating, Huntersville, NC
Classification: Class II
Status: Ongoing
Recall initiated: 2 Sep 2026
FDA classified: 2 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

2 Sep 2026	Recall initiated by company
2 Oct 2026	Classified by FDA	+30 days
14 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Which lots are affected?

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),

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Safeguard US Operating

All 4

Reported	Class	Recall	Company	Reason	Where
25 Sep 2024Device	CLASS II	Kits of Convenience containing 1 recalled by Safeguard US Operating	Safeguard US Operating	Other	Nationwide
25 Sep 2024Device	CLASS II	HAWK Warming Grid recalled by Safeguard US Operating	Safeguard US Operating	Other	Nationwide
25 Sep 2024Device	CLASS II	HAWK Advanced Hypothermia Management Set recalled	Safeguard US Operating	Other	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide