DeviceSignal · Recall classified
Cardinal Health 200, LLC
FDA classified a device recall on 2026-08-13 · Class II · Z-2942-2026
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) FAT GRAFT ADD KIT , Catalog Number…. Recall Z-2942-2026. The firm initiated it on 2026-07-14. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2942-2026
- 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) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,
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-2942-2026- 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
db909703b6bc0fd330c6d2c347a191920ae8a5260dbbabdb01e5462f1dbe097c- 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)