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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 SPIN

Class II
Recalling firm
AVID Medical, Inc.
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 products (lot / model / serial)
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) IHNE3
Units affected
16223 kits
Distribution pattern
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.
Firm location
Toano, VA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-3045-2026
Recall initiated
May 19, 2026
FDA classification date
August 28, 2026
FDA report date
September 9, 2026
FDA event ID
99469
Last updated on HTM Vibe
September 15, 2026
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