AVID Medical, Inc. recalls 1) NEURO
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Part / Item #
- (kit) ACNE73-01, UDI/DI 10809160458532, Kit
- Lot #
- 1649716; Model/
- Part / Item #
- (kit) ACNE73-01, UDI/DI 10809160458532, Kit
- Lot #
- 1666559; Model/
- Part / Item #
- (kit) ACNE73-01, UDI/DI 10809160458532, Kit
- Lot #
- 1649717; Model/
- Part / Item #
- (kit) ACNE73-03, UDI/DI 10809160513996, Kit
- Lot #
- 1696563; Model/
- Part / Item #
- (kit) AKCR19-01, UDI/DI 10809160459515, Kit
- Lot #
- 1650945; Model/
- Part / Item #
- (kit) AKCR19-01, UDI/DI 10809160459515, Kit
- Lot #
- 1666564; Model/
- Part / Item #
- (kit) AKCR19-01, UDI/DI 10809160459515, Kit
- Lot #
- 1664544; Model/
- Part / Item #
- (kit) AKCR19-01, UDI/DI 10809160459515, Kit
- Lot #
- 1666978; Model/
- Part / Item #
- (kit) ARMC017, UDI/DI 10809160506455, Kit
- Lot #
- 1685117; Model/
- Part / Item #
- (kit) ARMC017, UDI/DI 10809160506455, Kit
- Lot #
- 1688043; Model/
- Part / Item #
- (kit) ARMC017, UDI/DI 10809160506455, Kit
- Lot #
- 1688044; Model/
- Part / Item #
- (kit) BMHT016-05, UDI/DI 10809160468821, Kit
- Lot #
- 1666733; Model/
- Part / Item #
- (kit) BMHT016-05, UDI/DI 10809160468821, Kit
- Lot #
- 1659950; Model/
- Part / Item #
- (kit) BMHT112-03, UDI/DI 10809160457634, Kit
- Lot #
- 1649141; Model/
- Part / Item #
- (kit) BMHT112-03, UDI/DI 10809160404430, Kit
- Lot #
- 1606455; Model/
- Part / Item #
- (kit) DGNE75, UDI/DI 10809160468104, Kit
- Lot #
- 1659330; Model/
- Part / Item #
- (kit) DGNE75-02, UDI/DI 10809160510001, Kit
- Lot #
- 1688056; Model/
- Part / Item #
- (kit) DRNE75, UDI/DI 10809160467190, Kit
- Lot #
- 1658535; Model/
- Part / Item #
- (kit) DRNE75-01, UDI/DI 10809160503843, Kit
- Lot #
- 1681499; Model/
- Part / Item #
- (kit) DRNE75-01, UDI/DI 10809160503843, Kit
- Lot #
- 1691081; Model/
- Part / Item #
- (kit) DUCR36-01, UDI/DI 10809160497388, Kit
- Lot #
- 1675499; Model/
- Part / Item #
- (kit) DUCR36-02, UDI/DI 10809160513538, Kit
- Lot #
- 1691089; Model/
- Part / Item #
- (kit) DUNC42-01, UDI/DI 10809160497524, Kit
- Lot #
- 1675518; Model/
- Part / Item #
- (kit) DUNC42-01, UDI/DI 10809160497524, Kit
- Lot #
- 1686203; Model/
- Part / Item #
- (kit) DUNC42-01, UDI/DI 10809160497524, Kit
- Lot #
- 1686204; Model/
- Part / Item #
- (kit) DUNE88-01, UDI/DI 10809160498217, Kit
- Lot #
- 1675520; Model/
- Part / Item #
- (kit) DUSP98-01, UDI/DI 10809160497708, Kit
- Lot #
- 1680111; Model/
- Part / Item #
- (kit) DUSP98-02, UDI/DI 10809160513392, Kit
- Lot #
- 1691105; Model/
- Part / Item #
- (kit) EFCR86-01, UDI/DI 10809160442210, Kit
- Lot #
- 1633353; Model/
- Part / Item #
- (kit) EFCR86-01, UDI/DI 10809160456026, Kit
- Lot #
- 1694281; Model/
- Part / Item #
- (kit) EFCR86-01, UDI/DI 10809160456026, Kit
- Lot #
- 1691158; Model/
- Part / Item #
- (kit) EFCR86-01, UDI/DI 10809160442210, Kit
- Lot #
- 374076; Model/
- Part / Item #
- (kit) EFSP30-01, UDI/DI 10809160456187, Kit
- Lot #
- 1648983; Model/
- Part / Item #
- (kit) EFSP30-01, UDI/DI 10809160456187, Kit
- Lot #
- 1646886; Model/
- Part / Item #
- (kit) EFSP30-01, UDI/DI 10809160456187, Kit
- Lot #
- 1649731; Model/
- Part / Item #
- (kit) EFSP30-01, UDI/DI 10809160456187, Kit
- Lot #
- 1633403; Model/
- Part / Item #
- (kit) EFSP30-02, UDI/DI 10809160492024, Kit
- Lot #
- 1669417; Model/
- Part / Item #
- (kit) EFSP30-02, UDI/DI 10809160492024, Kit
- Lot #
- 1678530; Model/
- Part / Item #
- (kit) EFSP30-02, UDI/DI 10809160492024, Kit
- Lot #
- 1670304; Model/
- Part / Item #
- (kit) EFSP30-02, UDI/DI 10809160492024, Kit
- Lot #
- 1691551; Model/
- Part / Item #
- (kit) EFSP30-02, UDI/DI 10809160492024, Kit
- Lot #
- 1669415; Model/
- Part / Item #
- (kit) EFSP30-02, UDI/DI 10809160492024, Kit
- Lot #
- 1680385; Model/
- Part / Item #
- (kit) EURO009-09, UDI/DI 10809160414217, Kit
- Lot #
- 1649363; Model/
- Part / Item #
- (kit) IHCR36-01, UDI/DI 10809160477557, Kit
- Lot #
- 344863; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 343178; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 343377; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 343179; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 348826; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 348828; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 348829; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 348830; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 348834; Model/
- Part / Item #
- (kit) IHNE35-01, UDI/DI 10809160477724, Kit
- Lot #
- 348835; Model/
- Part / Item #
- (kit) JACK410-11, UDI/DI 10809160464991, Kit
- Lot #
- 1664733; Model/
- Part / Item #
- (kit) JACK410-11, UDI/DI 10809160464991, Kit
- Lot #
- 1656356; Model/
- Part / Item #
- (kit) JACK410-11, UDI/DI 10809160464991, Kit
- Lot #
- 1667191; Model/
- Part / Item #
- (kit) JACK410-11, UDI/DI 10809160464991, Kit
- Lot #
- 838447; Model/
- Part / Item #
- (kit) JACK410-11, UDI/DI 10809160464991, Kit
- Lot #
- 1664206; Model/
- Part / Item #
- (kit) JACK410-11, UDI/DI 10809160464991, Kit
- Lot #
- 1664732; Model/
- Part / Item #
- (kit) MAMC275-06, UDI/DI 10809160421666, Kit
- Lot #
- 1644895; Model/
- Part / Item #
- (kit) MAMC275-07, UDI/DI 10809160495902, Kit
- Lot #
- 1675387; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160453124, Kit
- Lot #
- 1652837; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160442999, Kit
- Lot #
- 1633247; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160442999, Kit
- Lot #
- 1633983; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160453124, Kit
- Lot #
- 1670241; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160442999, Kit
- Lot #
- 1636102; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160442999, Kit
- Lot #
- 1633985; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160453124, Kit
- Lot #
- 1670240; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160514719, Kit
- Lot #
- 1697302; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160453124, Kit
- Lot #
- 1674543; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160453124, Kit
- Lot #
- 1670238; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160453124, Kit
- Lot #
- 1680358; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160453124, Kit
- Lot #
- 1691128; Model/
- Part / Item #
- (kit) MCSP92-01, UDI/DI 10809160514719, Kit
- Lot #
- 1700133; Model/
- Part / Item #
- (kit) MECP05R, UDI/DI 10809160418109, Kit
- Lot #
- 1658933; Model/
- Part / Item #
- (kit) MECP05R, UDI/DI 10809160418109, Kit
- Lot #
- 1694755; Model/
- Part / Item #
- (kit) MECP05R, UDI/DI 10809160417331, Kit
- Lot #
- 1671174; Model/
- Part / Item #
- (kit) MEDF217-02, UDI/DI 10809160382912, Kit
- Lot #
- 1632022; Model/
- Part / Item #
- (kit) MEDF217-02, UDI/DI 10809160382912, Kit
- Lot #
- 1628605; Model/
- Part / Item #
- (kit) MEDF217-02, UDI/DI 10809160459706, Kit
- Lot #
- 1651140; Model/
- Part / Item #
- (kit) MEDF217-02, UDI/DI 10809160459706, Kit
- Lot #
- 1651139; Model/
- Part / Item #
- (kit) MEDF217-02, UDI/DI 10809160459706, Kit
- Lot #
- 1651141; Model/
- Part / Item #
- (kit) MEDF217-02, UDI/DI 10809160459706, Kit
- Lot #
- 1651142; Model/
- Part / Item #
- (kit) MENE06T, UDI/DI 10809160461327, Kit
- Lot #
- 1671525; Model/
- Part / Item #
- (kit) MENE06T, UDI/DI 10809160461327, Kit
- Lot #
- 1652669; Model/
- Part / Item #
- (kit) MENE06T, UDI/DI 10809160461327, Kit
- Lot #
- 1654982; Model/
- Part / Item #
- (kit) MENE06T, UDI/DI 10809160461327, Kit
- Lot #
- 1652667; Model/
- Part / Item #
- (kit) MENE06T, UDI/DI 10809160461327, Kit
- Lot #
- 1652668; Model/
- Part / Item #
- (kit) MENE06T, UDI/DI 10809160461327, Kit
- Lot #
- 1646454; Model/
- Part / Item #
- (kit) MHCP75-01, UDI/DI 10809160479568, Kit
- Lot #
- 345849; Model/
- Part / Item #
- (kit) MMOK007-03, UDI/DI 10809160460764, Kit
- Lot #
- 1696427; Model/
- Part / Item #
- (kit) MMTN012-04, UDI/DI 10809160444085, Kit
- Lot #
- 1644099; Model/
- Part / Item #
- (kit) MSMC108-01, UDI/DI 10809160427972, Kit
- Lot #
- 1623100; Model/
- Part / Item #
- (kit) MSMC108-01, UDI/DI 10809160427972, Kit
- Lot #
- 1650608; Model/
- Part / Item #
- (kit) MSMC108-01, UDI/DI 10809160427972, Kit
- Lot #
- 1623102; Model/
- Part / Item #
- (kit) MSMC108-01, UDI/DI 10809160427972, Kit
- Lot #
- 1639185; Model/
- Part / Item #
- (kit) MSMC108-01, UDI/DI 10809160427972, Kit
- Lot #
- 1657124; Model/
- Part / Item #
- (kit) NAMC413-07, UDI/DI 10809160374306, Kit
- Lot #
- 1652550; Model/
- Part / Item #
- (kit) NAMC433-05, UDI/DI 10809160417584, Kit
- Lot #
- 1629049; Model/
- Part / Item #
- (kit) NAMC433-05, UDI/DI 10809160417584, Kit
- Lot #
- 1656868; Model/
- Part / Item #
- (kit) NAMC434-08, UDI/DI 10809160417584, Kit
- Lot #
- 1649106; Model/
- Part / Item #
- (kit) NWHR010-03, UDI/DI 10809160456637, Kit
- Lot #
- 1681967; Model/
- Part / Item #
- (kit) NWHR010-03, UDI/DI 10809160456637, Kit
- Lot #
- 1656161; Model/
- Part / Item #
- (kit) NWHR010-03, UDI/DI 10809160456637, Kit
- Lot #
- 1688028; Model/
- Part / Item #
- (kit) NWHR010-03, UDI/DI 10809160456637, Kit
- Lot #
- 1675548; Model/
- Part / Item #
- (kit) NWHR010-03, UDI/DI 10809160456637, Kit
- Lot #
- 1664880; Model/
- Part / Item #
- (kit) NWHR010-03, UDI/DI 10809160456637, Kit
- Lot #
- 1684189; Model/
- Part / Item #
- (kit) OSCR20-01, UDI/DI 10809160436370, Kit
- Lot #
- 1664480; Model/
- Part / Item #
- (kit) RDLD001-14, UDI/DI 10809160467374, Kit
- Lot #
- 1658194; Model/
- Part / Item #
- (kit) RDLD001-14, UDI/DI 10809160467374, Kit
- Lot #
- 1658423; Model/
- Part / Item #
- (kit) RDLD001-14, UDI/DI 10809160467374, Kit
- Lot #
- 1658192; Model/
- Part / Item #
- (kit) RDLD001-14, UDI/DI 10809160467374, Kit
- Lot #
- 1691893; Model/
- Part / Item #
- (kit) RDLD008-14, UDI/DI 10809160467367, Kit
- Lot #
- 1658206; Model/
- Part / Item #
- (kit) SAMM031-18, UDI/DI 10809160494363, Kit
- Lot #
- 1672515; Model/
- Part / Item #
- (kit) SELF111-02, UDI/DI 10809160458808, Kit
- Lot #
- 1651950; Model/
- Part / Item #
- (kit) SELF111-02, UDI/DI 10809160458808, Kit
- Lot #
- 1652543; Model/
- Part / Item #
- (kit) SGAC31-02, UDI/DI 10809160469491, Kit
- Lot #
- 1661052; Model/
- Part / Item #
- (kit) SGAC31-03, UDI/DI 10809160489437, Kit
- Lot #
- 1667346; Model/
- Part / Item #
- (kit) SGAC31-03, UDI/DI 10809160489437, Kit
- Lot #
- 1673274; Model/
- Part / Item #
- (kit) SGAC31-03, UDI/DI 10809160489437, Kit
- Lot #
- 1667347; Model/
- Part / Item #
- (kit) SGAC31-03, UDI/DI 10809160489437, Kit
- Lot #
- 1668002; Model/
- Part / Item #
- (kit) SGAC31-03, UDI/DI 10809160489437, Kit
- Lot #
- 1691061; Model/
- Part / Item #
- (kit) SGAC31-03, UDI/DI 10809160489437, Kit
- Lot #
- 1700807; Model/
- Part / Item #
- (kit) SGSP11, UDI/DI 10809160461730, Kit
- Lot #
- 1656113; Model/
- Part / Item #
- (kit) SGSP11-03, UDI/DI 10809160511145, Kit
- Lot #
- 1668007; Model/
- Part / Item #
- (kit) SGSP11-03, UDI/DI 10809160511145, Kit
- Lot #
- 1691439; Model/
- Part / Item #
- (kit) SGSP11-03, UDI/DI 10809160511145, Kit
- Lot #
- 1668009; Model/
- Part / Item #
- (kit) SGSP11-03, UDI/DI 10809160511145, Kit
- Lot #
- 1668008; Model/
- Part / Item #
- (kit) SGSP44-02, UDI/DI 10809160469620, Kit
- Lot #
- 1661236; Model/
- Part / Item #
- (kit) SGSP44-03, UDI/DI 10809160490037, Kit
- Lot #
- 1668013; Model/
- Part / Item #
- (kit) SGSP44-03, UDI/DI 10809160490037, Kit
- Lot #
- 1676432; Model/
- Part / Item #
- (kit) SGSP44-03, UDI/DI 10809160490037, Kit
- Lot #
- 1668011; Model/
- Part / Item #
- (kit) SGSP44-03, UDI/DI 10809160490037, Kit
- Lot #
- 1668014; Model/
- Part / Item #
- (kit) SGSP44-03, UDI/DI 10809160490037, Kit
- Lot #
- 1667304; Model/
- Part / Item #
- (kit) SGSP44-03, UDI/DI 10809160490037, Kit
- Lot #
- 1668012; Model/
- Part / Item #
- (kit) SGSP91, UDI/DI 10809160462102, Kit
- Lot #
- 1656747; Model/
- Part / Item #
- (kit) SGSP91, UDI/DI 10809160462102, Kit
- Lot #
- 1653016; Model/
- Part / Item #
- (kit) SGSP91-02, UDI/DI 10809160469644, Kit
- Lot #
- 1661240; Model/
- Part / Item #
- (kit) SGSP91-03, UDI/DI 10809160511558, Kit
- Lot #
- 1671768; Model/
- Part / Item #
- (kit) SGSP91-03, UDI/DI 10809160511558, Kit
- Lot #
- 1671769; Model/
- Part / Item #
- (kit) SGSP91-03, UDI/DI 10809160511558, Kit
- Lot #
- 1667616; Model/
- Part / Item #
- (kit) SGSP91-03, UDI/DI 10809160511558, Kit
- Lot #
- 1673361; Model/
- Part / Item #
- (kit) SGSP91-03, UDI/DI 10809160511558, Kit
- Lot #
- 1673362; Model/
- Part / Item #
- (kit) SGSP91-03, UDI/DI 10809160511558, Kit
- Lot #
- 1691066; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1574836; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1579673; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1582963; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1588397; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1589834; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1590905; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1603715; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1610818; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1655825; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1609281; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1603716; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1648191; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1653849; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1611976; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1622358; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1617996; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1660322; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160363539, Kit
- Lot #
- 1665018; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160502297, Kit
- Lot #
- 1680232; Model/
- Part / Item #
- (kit) SHND416-02, UDI/DI 10809160502297, Kit
- Lot #
- 1691224; Model/
- Part / Item #
- (kit) SHOR003-15, UDI/DI 10809160390498, Kit
- Lot #
- 1566522; Model/
- Part / Item #
- (kit) SHOR003-15, UDI/DI 10809160390498, Kit
- Lot #
- 1568213; Model/
- Part / Item #
- (kit) SHOR003-15, UDI/DI 10809160411513, Kit
- Lot #
- 1612999; Model/
- Part / Item #
- (kit) SHOR003-15, UDI/DI 10809160411513, Kit
- Lot #
- 1613422; Model/
- Part / Item #
- (kit) SHOR003-15, UDI/DI 10809160411513, Kit
- Lot #
- 1644462; Model/
- Part / Item #
- (kit) SLCN72-01, UDI/DI 10809160446416, Kit
- Lot #
- 1636631; Model/
- Part / Item #
- (kit) SLCN72-02, UDI/DI 10809160457030, Kit
- Lot #
- 1647141; Model/
- Part / Item #
- (kit) SLCN72-03, UDI/DI 10809160470701, Kit
- Lot #
- 1667104; Model/
- Part / Item #
- (kit) SLCN72-03, UDI/DI 10809160470701, Kit
- Lot #
- 1662160; Model/
- Part / Item #
- (kit) SLCN72-03, UDI/DI 10809160470701, Kit
- Lot #
- 1662162; Model/
- Part / Item #
- (kit) SLCN72-03, UDI/DI 10809160470701, Kit
- Lot #
- 1668135; Model/
- Part / Item #
- (kit) SLCN72-03, UDI/DI 10809160470701, Kit
- Lot #
- 1691204; Model/
- Part / Item #
- (kit) UDCP57-01, UDI/DI 10809160483404, Kit
- Lot #
- 345399; Model/
- Part / Item #
- (kit) UMIA104-11, UDI/DI 10809160465189, Kit
- Lot #
- 1664831; Model/
- Part / Item #
- (kit) UMIA104-11, UDI/DI 10809160465189, Kit
- Lot #
- 1664832; Model/
- Part / Item #
- (kit) USMA005, UDI/DI 10809160388297, Kit
- Lot #
- 1669219; Model/
- Part / Item #
- (kit) USMA005, UDI/DI 10809160388297, Kit
- Lot #
- 1680592; Model/
- Part / Item #
- (kit) VAML012-07, UDI/DI 10809160379011, Kit
- Lot #
- 1612231; Model/
- Part / Item #
- (kit) VAML028-06, UDI/DI 10809160379127, Kit
- Lot #
- 1626107; Model/
- Part / Item #
- (kit) VAPX009-02, UDI/DI 10809160302491, Kit
- Lot #
- 1694165; Model/
- Part / Item #
- (kit) VMCC024-14, UDI/DI 10809160458891, Kit
- Lot #
- 1653475; Model/
- Part / Item #
- (kit) VMED009-05, UDI/DI 10809160487808, Kit
- Lot #
- 1663908; Model/
- Part / Item #
- (kit) VMED009-05, UDI/DI 10809160487808, Kit
- Lot #
- 1663979; Model/
- Part / Item #
- (kit) WEAC53-01, UDI/DI 10809160485347, Kit
- Lot #
- 349078; Model/
- Part / Item #
- (kit) WECR41-01, UDI/DI 10809160485392, Kit
- Lot #
- 348573; Model/
- Part / Item #
- (kit) WECR41-01, UDI/DI 10809160485392, Kit
- Lot #
- 348575; Model/
- Part / Item #
- (kit) WECR41-01, UDI/DI 10809160485392, Kit
- Lot #
- 348673; Model/
- Part / Item #
- (kit) WELL73-01, UDI/DI 10809160485545, Kit
- Lot #
- 344499; Model/
- Part / Item #
- (kit) WELL73-01, UDI/DI 10809160485545, Kit
- Lot #
- 348358; Model/
- Part / Item #
- (kit) WELL73-01, UDI/DI 10809160485545, Kit
- Lot #
- 348360; Model/
- Part / Item #
- (kit) WELL73-01, UDI/DI 10809160485545, Kit
- Lot #
- 348364; Model/
- Part / Item #
- (kit) WELL73-01, UDI/DI 10809160485545, Kit
- Lot #
- 348402; Model/
- Part / Item #
- (kit) WELL73-01, UDI/DI 10809160485545, Kit
- Lot #
- 348409; Model/
- Part / Item #
- (kit) WKMC114-03, UDI/DI 10809160448069, Kit
- Lot #
- 1652912; Model/
- Part / Item #
- (kit) WKMC114-03, UDI/DI 10809160448069, Kit
- Lot #
- 1660282; Model/
- Part / Item #
- (kit) WKMC125-03, UDI/DI 10809160448113, Kit
- Lot #
- 1641373; Model/
- Part / Item #
- (kit) WRNM030-21, UDI/DI 10809160441961, Kit
- Lot #
- 1661529
Show 392 more code fieldsShow fewer
What the firm is doing
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."
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3045-2026
- FDA device classification · OJGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 882.4525The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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