Device recalls

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Cat…

Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…

Open, ClassifiedNonconforming Material/ComponentZ-2949-2026
Open FDA's page for this record
Cfres ID
221480
Product res number
Z-2949-2026
Event date initiated
2026-07-14
Event date posted
2026-08-13
Recall status
Open, Classified
Res event number
99380
Product code
OJK
Firm FEI number
3001236905
Recalling firm
Cardinal Health 200, LLC
Address 1
3651 Birchwood Dr
City
Waukegan
State
IL
Postal code
60085-8337
Additional info contact
Cardinal Health Quality Systems 800-292-9332
Root cause description
Nonconforming Material/Component
Product quantity
616 kits
Distribution pattern
US Nationwide. Canada.
Product description

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

Code info

1) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14039 ; 2) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 3) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 4) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14039 ; 5) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192-1 ; 6) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-5 ; 7) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 8) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 9) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14813 ; 10) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192 ; 11) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-1 ; 12) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-6 ; 13) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-7 ; 14) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-1 ; 15) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 6033 ; 16) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160-2 ; 17) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 10392 ; 18) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-2 ; 19) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 11020 ; 20) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1 ; 21) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160 ; 22) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1

Reason for recall

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Action

Cardinal Health issued an URGENT: PRODUCT CORRECTION notice to its consignees on 7/14/2026 via FedEx. The notice explained the issue and enclosed a copy of the recall notice issued by the supplier of the affected component which explained the risk and provided details on the affected component. The notice issued by Cardinal Health requested that consignee notify its clinicians, affix a warning label to the affected kits in their inventory, and respond using the acknowledgement form via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: gmb-FieldCorrectiveAction@cardinalhealth.com. The warning label requests that the affected component be removed and discarded. For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166. Distributors were direct to notify their customers. For questions, additional labels, or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.

Harmonized identifiers (openFDA)
Device name
Eye Tray
Medical specialty description
Ophthalmic
Regulation number
886.4790
Device class
2
Registration number
3026197444, 3009732568, 3004895419, 3018077422, 1610287, 1043214, 3004111573, 1221144, 3002807314, 1030451, 9616088, 1047429, 3014925393, 1423395, 1121203, 2029015, 3029990829, 3004122598, 1423537, 3009337401, 1643817, 3007329020, 3008102042, 2320762, 1061124, 1644019, 1720929, 1928237, 3015173212, 3005595283, 3005012805, 3003365815, 1650907, 2032098, 3045816907, 1054241, 3019924, 3010155661, 3011144486, 1055236 +9 more
FEI number
3002616700, 3026197444, 3002902735, 3009732568, 3002681132, 3004895419, 3003040625, 1317628, 3018077422, 1610287, 1043214, 3004111573, 1221144, 3002807314, 1030451, 3014925393, 1047429, 3000717925, 3003058448, 3004122598, 3029990829, 3009337401, 1000112968, 1643817, 3007329020, 1720929, 1928237, 3015173212, 3005595283, 3005012805, 1000112877, 3003365815, 1000136269, 1000160458, 3045816907, 3002924544, 3010155661, 3011144486, 3019924, 3005034064 +9 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.