CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Cardinal Health Presource Kits: Septo Rhino Pack recalled
Cardinal Health 200 is recalling Cardinal Health Presource Kits: Septo Rhino Pack, distributed nationwide in the US. The recall was initiated on 14 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2946-2026
- FDA event ID
- 99380
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2026
- FDA classified
- 13 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 14 Jul 2026 | Recall initiated by company | |
| 13 Aug 2026 | Classified by FDA | +30 days |
| 19 Aug 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Product as listed by the FDA
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE R , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL
Where it was distributed
US Nationwide. Canada.
Questions about this recall
Why was it recalled?
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Which lots are affected?
1) SEN73NSKCF, UDI-DI: 10888439509304(each), 50888439509302(case), Lot Number: 3024-2 ; 2) SNE30CNOHE, UDI-DI: 10195594506230(each), 50195594506238(case), Lot Number: 93845 ; 3) SNE30CRJGY, UDI-DI: 10195594453992(each), 50195594453990(case), Lot Number: 4730 ; 4) SNE43NEE13, UDI-DI: 10198956470965(each), 50198956470963(case), Lot Number: 14039 ; 5) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 6033 ; 6) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 4366 ; 7) SNE5CLPB13, UDI-DI: 10197106328132(each), 50197106328130(case), Lot Number: 7390 ; 8) SNE69PSKR4, UDI-DI: 10197106895580(each), 50197106895588(case), Lot Number: 13673 ; 9) SNE7CSHY15, UDI-DI: 10197106979006(each), 50197106979004(case), Lot Number: 13673 ; 10) SNE7CSHY16, UDI-DI: 10198956026582(each), 50198956026580(case), Lot Number: 14813 ; 11) SOP30ODSCL, UDI-DI: 10197106705599(each), 50197106705597(case), Lot Number: 14813
Where was it sold?
US Nationwide. Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99380This product is part of a recall event; the main page for the event is Cardinal Health Presource Kits: Harmonized Spine Vch Phc Pack recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cardinal Health Presource Kits: Harmonized Spine Vch Phc Pack recalled | Cardinal Health 200 | Other | Nationwide | |
| CLASS II | Cardinal Health Presource Kits: Newnan Smr Pack recalled | Cardinal Health 200 | Other | Nationwide | |
| CLASS II | Cardinal Health Presource Kits: Basic Pack recalled | Cardinal Health 200 | Other | Nationwide |
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |