DeviceSignal · Recall classified
Cardinal Health 200, LLC
FDA classified a device recall on 2026-08-13 · Class II · Z-2946-2026
EventRecall classified
Effective2026-08-13
ClassificationClass II
On 2026-08-13 the FDA classified a device recall from Cardinal Health 200, LLC as Class II. Product: Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number…. Recall Z-2946-2026. The firm initiated it on 2026-07-14. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2946-2026
- Classification
- Class II
- Classified on
- 2026-08-13
- Initiated on
- 2026-07-14
- Firm
- Cardinal Health 200, LLC
- Reason
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Product
- 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
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2946-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
4f2f637ad324ace9ca41f827af448db1322da208a9d8a77370b95cb51ae2fb85- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)