Class 2 Device Recall Halyard

• Date Initiated by Firm: May 19, 2026
• Date Posted: August 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3045-2026
• Recall Event ID: 99469
• Product Classification: Neurological tray - Product Code OJG
• Product: 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02; 9) DRAH NEURO LAMINECTOMY SNEDHDN,(kit) DRNE75; 10) DRAH NEURO LAMINECTOMY SNEDHDN, (kit) DRNE75-01; 11) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-01; 12) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-02; 13) NEURO CRANIOTOMY PK SNE23C1116, (kit) DUNC42-01; 14) PEDS NEURO PACK SNE2301147, (kit) DUNE88-01; 15) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-01; 16) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-02; 17) CRANI PACK 712638, (kit) EFCR86-01; 18) SPINE PACK 712040, (kit) EFSP30-01; 19) SPINE PACK 712040, (kit) EFSP30-02; 20) CRANIOTOMY TRAY, (kit) EURO009-09; 21) CRANI PACK, (kit) IHCR36-01; 22) NEURO PACK, (kit) IHNE35-01; 23) CRANIOTOMY PACK, (kit) JACK410-11; 24) BASIC NEURO PACK, (kit) MAMC275-06; 25) BASIC NEURO PACK, (kit) MAMC275-07; 26) SPINE CRANI PACK, (kit) MCSP92-01; 27) CRANIOTOMY PACK, (kit) MECP05R; 28) SPINE TRAY GLOBALMICROSURG, (kit) MEDF217-02; 29) NEURO BASIC PACK, (kit) MENE06T; 30) CRANIAL PACK - 205992, (kit) MHCP75-01; 31) NEURO PACK, (kit) MMOK007-03; 32) NEURO PACK, (kit) MMTN012-04; 33) CRANIOTOMY PACK SNECGCRM11, (kit) MSMC108-01; 34) NEURO ANT CERV LAMI ADD A PACK, (kit) NAMC413-07; 35) STRL NEURO LUMB LAMI ADD A PK, (kit) NAMC433-05; 36) NEURO CRANI ADD A PACK, (kit) NAMC434-08; 37) NEURO PACK, (kit) NWHR010-03; 38) CRANIOTOMY PACK OSBORN 176518, (kit) OSCR20-01; 39) NEURO PACK, (kit) RDLD001-14; 40) CRANI PACK, (kit) RDLD008-14; 41) NEURO LUMBAR CERVICAL PACK,(kit) SAMM031-18; 42) CRANIOTOMY PACK, (kit) SELF111-02; 43) PELHAM ACDF, (kit) SGAC31-02; 44) PELHAM ACDF, (kit) SGAC31-03; 45) PELHAM MINA SPINE, (kit) SGSP11; 46) PELHAM MINA SPINE, (kit) SGSP11-03; 47) PELHAM SPINE, (kit) SGSP44-02; 48) PELHAM SPINE, (kit) SGSP44-03; 49) SPINE, (kit) SGSP91; 50) SPINE, (kit) SGSP91-02; 51) SPINE, (kit) SGSP91-03; 52) NEURO SPINAL TRAY SHANDS JACKS, (kit) SHND416-02; 53) DR. DELASOTTA NEURO NECK, (kit) SHOR003-15; 54) CRANI PACK, (kit) SLCN72-01; 55) CRANI PACK, (kit) SLCN72-02; 56) CRANI PACK, (kit) SLCN72-03; 57) CRANI PACK - 208400, (kit) UDCP57-01; 58) NEURO TRAY-LF, (kit) UMIA104-11; 59) CRANIOTOMY PACK, (kit) USMA005; 60) CERVICAL NEURO PACK PGYBK, (kit) VAML012-07; 61) LUMBAR NEURO PACK PGYBK, (kit) VAML028-06; 62) NASAL SINUS, (kit) VAPX009-02; 63) LUMBAR LAMINECTOMY TRAY, (kit) VMCC024-14; 64) VA LUMBAR LAMINECTOMY, (kit) VMED009-05; 65) ANTERIOR CERVICAL PACK, (kit) WEAC53-01; 66) CRANI PACK, (kit) WECR41-01; 67) LUMBAR LAMINECTOMY PACK,67) LUMBAR LAMINECTOMY PACK, Model/Item Number (kit) WELL73-01; 68) LUMBAR LAMINECTOMY, (kit) WKMC114-03; 69) CRANIOTOMY PK, (kit) WKMC125-03; 70) DISKECTOMY PACK, (kit) WRNM030-21.
• Code Information: Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649716; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1666559; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649717; Model/Item Number (kit) ACNE73-03, UDI/DI 10809160513996, Kit Lot Number 1696563; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1650945; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666564; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1664544; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666978; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1685117; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688043; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688044; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1666733; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1659950; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160457634, Kit Lot Number 1649141; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160404430, Kit Lot Number 1606455; Model/Item Number (kit) DGNE75, UDI/DI 10809160468104, Kit Lot Number 1659330; Model/Item Number (kit) DGNE75-02, UDI/DI 10809160510001, Kit Lot Number 1688056; Model/Item Number (kit) DRNE75, UDI/DI 10809160467190, Kit Lot Number 1658535; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1681499; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1691081; Model/Item Number (kit) DUCR36-01, UDI/DI 10809160497388, Kit Lot Number 1675499; Model/Item Number (kit) DUCR36-02, UDI/DI 10809160513538, Kit Lot Number 1691089; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1675518; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686203; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686204; Model/Item Number (kit) DUNE88-01, UDI/DI 10809160498217, Kit Lot Number 1675520; Model/Item Number (kit) DUSP98-01, UDI/DI 10809160497708, Kit Lot Number 1680111; Model/Item Number (kit) DUSP98-02, UDI/DI 10809160513392, Kit Lot Number 1691105; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 1633353; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1694281; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1691158; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 374076; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1648983; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1646886; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1649731; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1633403; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669417; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1678530; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1670304; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1691551; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669415; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1680385; Model/Item Number (kit) EURO009-09, UDI/DI 10809160414217, Kit Lot Number 1649363; Model/Item Number (kit) IHCR36-01, UDI/DI 10809160477557, Kit Lot Number 344863; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343178; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343377; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343179; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348826; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348828; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348829; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348830; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348834; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348835; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664733; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1656356; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1667191; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 838447; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664206; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664732; Model/Item Number (kit) MAMC275-06, UDI/DI 10809160421666, Kit Lot Number 1644895; Model/Item Number (kit) MAMC275-07, UDI/DI 10809160495902, Kit Lot Number 1675387; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1652837; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633247; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633983; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670241; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1636102; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633985; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670240; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1697302; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1674543; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670238; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1680358; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1691128; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1700133; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1658933; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1694755; Model/Item Number (kit) MECP05R, UDI/DI 10809160417331, Kit Lot Number 1671174; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1632022; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1628605; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651140; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651139; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651141; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651142; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1671525; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652669; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1654982; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652667; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652668; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1646454; Model/Item Number (kit) MHCP75-01, UDI/DI 10809160479568, Kit Lot Number 345849; Model/Item Number (kit) MMOK007-03, UDI/DI 10809160460764, Kit Lot Number 1696427; Model/Item Number (kit) MMTN012-04, UDI/DI 10809160444085, Kit Lot Number 1644099; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623100; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1650608; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623102; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1639185; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1657124; Model/Item Number (kit) NAMC413-07, UDI/DI 10809160374306, Kit Lot Number 1652550; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1629049; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1656868; Model/Item Number (kit) NAMC434-08, UDI/DI 10809160417584, Kit Lot Number 1649106; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1681967; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1656161; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1688028; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1675548; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1664880; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1684189; Model/Item Number (kit) OSCR20-01, UDI/DI 10809160436370, Kit Lot Number 1664480; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658194; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658423; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658192; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1691893; Model/Item Number (kit) RDLD008-14, UDI/DI 10809160467367, Kit Lot Number 1658206; Model/Item Number (kit) SAMM031-18, UDI/DI 10809160494363, Kit Lot Number 1672515; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1651950; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1652543; Model/Item Number (kit) SGAC31-02, UDI/DI 10809160469491, Kit Lot Number 1661052; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667346; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1673274; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667347; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1668002; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1691061; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1700807; Model/Item Number (kit) SGSP11, UDI/DI 10809160461730, Kit Lot Number 1656113; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668007; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1691439; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668009; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668008; Model/Item Number (kit) SGSP44-02, UDI/DI 10809160469620, Kit Lot Number 1661236; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668013; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1676432; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668011; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668014; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1667304; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668012; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1656747; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1653016; Model/Item Number (kit) SGSP91-02, UDI/DI 10809160469644, Kit Lot Number 1661240; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671768; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671769; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1667616; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673361; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673362; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1691066; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1574836; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1579673; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1582963; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1588397; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1589834; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1590905; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603715; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1610818; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1655825; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1609281; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603716; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1648191; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1653849; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1611976; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1622358; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1617996; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1660322; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1665018; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1680232; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1691224; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1566522; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1568213; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1612999; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1613422; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1644462; Model/Item Number (kit) SLCN72-01, UDI/DI 10809160446416, Kit Lot Number 1636631; Model/Item Number (kit) SLCN72-02, UDI/DI 10809160457030, Kit Lot Number 1647141; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1667104; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662160; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662162; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1668135; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1691204; Model/Item Number (kit) UDCP57-01, UDI/DI 10809160483404, Kit Lot Number 345399; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664831; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664832; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1669219; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1680592; Model/Item Number (kit) VAML012-07, UDI/DI 10809160379011, Kit Lot Number 1612231; Model/Item Number (kit) VAML028-06, UDI/DI 10809160379127, Kit Lot Number 1626107; Model/Item Number (kit) VAPX009-02, UDI/DI 10809160302491, Kit Lot Number 1694165; Model/Item Number (kit) VMCC024-14, UDI/DI 10809160458891, Kit Lot Number 1653475; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663908; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663979; Model/Item Number (kit) WEAC53-01, UDI/DI 10809160485347, Kit Lot Number 349078; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348573; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348575; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348673; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 344499; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348358; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348360; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348364; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348402; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348409; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1652912; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1660282; Model/Item Number (kit) WKMC125-03, UDI/DI 10809160448113, Kit Lot Number 1641373; Model/Item Number (kit) WRNM030-21, UDI/DI 10809160441961, Kit Lot Number 1661529.
• FEI Number: 1047429
• Recalling Firm/ Manufacturer: AVID Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Marlene Jones; 470-280-4277
• Manufacturer Reason for Recall: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
• FDA Determined Cause: Material/Component Contamination
• Action: Owens & Minor issued an URGENT: MEDICAL DEVICE RECALL NOTIFICATION to its consignees on 5/19/2026 via email. The notice explained the issue, potential risk to health and requested the following: "ACTIONS TO TAKE: " Identify, segregate, and quarantine all impacted product. " Add recall labels to affected Avid kits to ensure all users are aware of the actions to discard the impacted component. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness."
• Quantity in Commerce: 16223 kits
• Distribution: US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.