Cardinal Health
FDA adverse event reports naming Cardinal Health as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CARDINAL HEALTH.
- Total reports
- 5,231
- Deaths
- 57
- Injuries
- 1,049
- Malfunctions
- 3,635
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Device, Hemostasis, VascularMGB1,152
- Tubes, Gastrointestinal (And Accessories)KNT753
- Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY243
- Pump, Infusion, EnteralLZH224
- Needle, Hypodermic, Single LumenFMI182
- Syringe, PistonFMF155
- Surgeon'S GlovesKGO119
- Bottle, Collection, VacuumKDQ113
- Pack, Hot Or Cold, DisposableIMD111
- Gastrointestinal Tubes With Enteral Specific ConnectorsPIF111
Recent recalls
- 2026-08-13Open, ClassifiedNonconforming Material/Component
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) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) EDGECOMBE 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 ,
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.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
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.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
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.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;
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.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
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 ROSEVILLE , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL
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.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;
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.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63
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.
- 2026-08-13Open, ClassifiedNonconforming Material/Component
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
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.
- 2026-04-02Open, ClassifiedUnder Investigation by firm
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
- 2026-01-28Open, ClassifiedError in labeling
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
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