Cardinal Health Inc.

FDA Regulatory Profile

Summary

Total Recalls
315 (10 Class I)
510(k) Clearances
28
Inspections
113
Compliance Actions
0

Known Names

cardinal health, cardinal health 200, cardinal health singapore 225

Recent Recalls

NumberClassProductDate
D-0597-2025Class IIEnoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packagAugust 5, 2025
D-0573-2025Class IIRECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA,July 30, 2025
D-0571-2025Class IIXolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San FranciJuly 30, 2025
D-0572-2025Class IIXolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080July 30, 2025
D-0393-2025Class IIWegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For SubcutaApril 9, 2025
D-0134-2024Class ILEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL)October 31, 2023
D-0135-2024Class ILEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mOctober 31, 2023
D-0132-2024Class ILEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, SOctober 31, 2023
D-0136-2024Class ILEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, SteriOctober 31, 2023
D-0131-2024Class ILEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline HydrochlOctober 31, 2023
D-0133-2024Class ILEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper boOctober 31, 2023
Z-0356-2023Class IIDover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 November 1, 2022
Z-0359-2023Class IIDover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage fNovember 1, 2022
Z-0361-2023Class IIDover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 100November 1, 2022
Z-0360-2023Class IIDover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 100November 1, 2022
Z-0357-2023Class IIDover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code:November 1, 2022
Z-0358-2023Class IIDover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product CodNovember 1, 2022
D-0882-2022Class IHumalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, MApril 5, 2022
D-0883-2022Class IITrulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly April 5, 2022
D-0884-2022Class IITrulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli LillApril 5, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNDecember 20, 2022
K211765Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse GownNovember 23, 2021
K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with ChemotheJune 15, 2017
K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingJuly 25, 2016
K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingJuly 11, 2016
K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for UseMay 12, 2016
K122696POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)January 31, 2013
K121897PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVESJuly 27, 2012
K120934PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50May 23, 2012
K111878PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVESSeptember 29, 2011
K110272STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGJune 8, 2011
K111015STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATINGMay 6, 2011
K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSApril 15, 2011
K103249NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LADecember 16, 2010
K102500STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATINGNovember 4, 2010
K101811PROTEGRITY SMT LATEX SURGICALGLOVESOctober 15, 2010
K092684LAPAROSCOPIC RETRACTORSJanuary 22, 2010
K090915STERILE WATER FOR INHALATION FLEX BAG, USPNovember 18, 2009
K093300ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVESOctober 30, 2009
K092304ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVESSeptember 15, 2009