Fresh Recalls

FDAClass II · Medical device · Recall Z-0081-2027 · Recalled October 14, 2026

Battle Bandage recall — Safeguard US Operating LLC

Agency report date: October 14, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Battle Bandage
Company / brand
Safeguard US Operating
Lot / serial / date codes
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.
Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Battle Bandage recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-0081-2027
Brand
All Safeguard US Operating recalls
Classification
Class II
Units affected
46,881
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Huntersville, NC, United States
Firm address
13359 Reese Blvd E, N/A, 28078-6591

Identifying details (verbatim from the notice)

Product codes / lots
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.
Firm notified the public via
Letter
FDA event ID
99814
Recall initiated
September 2, 2026
FDA classified
October 2, 2026
FDA report date
October 14, 2026

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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