Recall Register

Food, drugs, devices › Firms

Cardinal Health

FDA recalling firm · 12 enforcement events · 75 product records · 2012–2022 · IL, MA

Cardinal Health has 12 FDA enforcement events on this register (75 product records) between 2012 and 2022: 10 device, 1 drug and 1 food; the busiest year was 2016 with 3.

8% of its events are Class I; the most common class is Class II (10). 3 events are listed as ongoing; the recalling firm's address is in IL and MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
1 Nov 2022Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patientDeviceClass II6Ongoing
2 Nov 2021SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474DeviceClass II11Ongoing
4 Aug 2021Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.DeviceClass I3Ongoing
11 Jan 2020AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NADeviceClass II39Terminated
20 Jul 2016BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is…DeviceClass II1Terminated
27 Jun 2016The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.DeviceClass II1Terminated
29 Feb 2016Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.DeviceClass II1Terminated
25 Aug 2015Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.DeviceClass II1Terminated
23 Dec 2014Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.DeviceClass II1Terminated
2 Oct 2013Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701DrugClass III1Terminated
18 Dec 2012Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of…DeviceClass II9Terminated
13 Nov 2012Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4FoodClass II1Terminated

By type and class

Device10
Drug1
Food1
Class II10
Class I1
Class III1

Class I: 8% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Cardinal Health by year initiated.

Questions and answers

How many FDA recalls has Cardinal Health had?

12 enforcement events (75 product records) on this register, 2012–2022: 10 device, 1 drug, 1 food.

Are any Cardinal Health recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Cardinal Health recalls?

10 Class II, 1 Class I, 1 Class III. 8% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.