Cardinal Health Inc.
Cardinal Health Inc. appears in FDA public data with 315 recalls — including 10 Class I (most serious) —, 28 510(k) clearances, 117 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0597-2025, Class II) was initiated on August 5, 2025. Its most recent 510(k) clearance was granted on December 20, 2022.
Summary
- Total Recalls
- 315 (10 Class I)
- 510(k) Clearances
- 28
- Inspections
- 117
- Compliance Actions
- 0
Known Names
cardinal health, cardinal health 200, cardinal health care, cardinal health singapore 225
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0597-2025 | Class II | Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packag | August 5, 2025 |
| D-0573-2025 | Class II | RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, | July 30, 2025 |
| D-0571-2025 | Class II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Franci | July 30, 2025 |
| D-0572-2025 | Class II | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080 | July 30, 2025 |
| D-0393-2025 | Class II | Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcuta | April 9, 2025 |
| D-0135-2024 | Class I | LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 m | October 31, 2023 |
| D-0136-2024 | Class I | LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Steri | October 31, 2023 |
| D-0134-2024 | Class I | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) | October 31, 2023 |
| D-0132-2024 | Class I | LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, S | October 31, 2023 |
| D-0131-2024 | Class I | LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochl | October 31, 2023 |
| D-0133-2024 | Class I | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bo | October 31, 2023 |
| Z-0358-2023 | Class II | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Cod | November 1, 2022 |
| Z-0361-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 100 | November 1, 2022 |
| Z-0356-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 | November 1, 2022 |
| Z-0359-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage f | November 1, 2022 |
| Z-0357-2023 | Class II | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: | November 1, 2022 |
| Z-0360-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 100 | November 1, 2022 |
| D-0882-2022 | Class I | Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, M | April 5, 2022 |
| D-0883-2022 | Class II | Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly | April 5, 2022 |
| D-0884-2022 | Class II | Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lill | April 5, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMN | December 20, 2022 |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown | November 23, 2021 |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemothe | June 15, 2017 |
| K160411 | Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating | July 25, 2016 |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | July 11, 2016 |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use | May 12, 2016 |
| K122696 | POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) | January 31, 2013 |
| K121897 | PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES | July 27, 2012 |
| K120934 | PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 | May 23, 2012 |
| K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | September 29, 2011 |
| K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | June 8, 2011 |
| K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | May 6, 2011 |
| K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | April 15, 2011 |
| K103249 | NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LA | December 16, 2010 |
| K102500 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | November 4, 2010 |
| K101811 | PROTEGRITY SMT LATEX SURGICALGLOVES | October 15, 2010 |
| K092684 | LAPAROSCOPIC RETRACTORS | January 22, 2010 |
| K090915 | STERILE WATER FOR INHALATION FLEX BAG, USP | November 18, 2009 |
| K093300 | ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES | October 30, 2009 |
| K092304 | ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES | September 15, 2009 |