FDA Medical devices recall ·
1) NEURO, (kit) ACNE73-01 recall
- Recall number
- Z-3045-2026
- Date
- (initiated May 19, 2026)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 16223 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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) DRNE75-0
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.
States: Arizona California Colorado Florida Georgia Iowa Illinois Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska Ohio Pennsylvania South Dakota Texas Utah Washington Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3045-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.