The Recall Desk

Manufacturer

Cardinal Health

75 recalls in our database name Cardinal Health as the manufacturing or recalling firm.

What the numbers show

Total
75
Critical
1
Severe
22
Most recent
2022-12-14

Of the 75 recalls from Cardinal Health we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 22 (29%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 75

  • HighFDA (Devices)·Z-1010-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 Non-Reinf Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2020·2020-02-12

    Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling RoyalSilk XLARGE gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK XLARGE, Gown. Item Code 9548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 Fabric Reinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2917-2016·2016-10-12

    Cardinal Health Recalls Blue Impervious Gowns for Flammability Defect

    Cardinal Health is recalling Blue Impervious Gowns, X-Large, because they failed to meet federal flammability standards for vinyl plastic film.

    Product
    BLUE 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2713-2016·2016-09-07

    Cardinal Health Recalls Arterial Blood Gas Kits Missing Safety Clasp

    Cardinal Health is recalling specific lots of 9025TRU Arterial Blood Gas Kits because they are missing a locking clasp component, posing a potential safety risk.

    Product
    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2016·2016-04-13

    Cardinal Health Recalls Gomco Style Circumcision Clamp Trays Due to Labeling Error

    Cardinal Health is recalling Gomco Style Circumcision Clamp Trays because two lots were labeled as containing 1.1cm clamps but actually contained 1.3cm clamps.

    Product
    Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2016·2015-10-28

    Cardinal Health Recalls Ambitex NMD400 Nitrile Exam Gloves Due to Leak Test Failure

    Cardinal Health is recalling Ambitex NMD400 Nitrile Exam Gloves (size medium) because samples failed FDA water leak tests, compromising their barrier function.

    Product
    Ambitex 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0489-2015·2015-04-22

    Cardinal Health Recalls Potassium Chloride Tablets Due to Incorrect Package Insert

    Cardinal Health is recalling specific lots of potassium chloride extended-release tablets because they were packaged with the wrong package insert.

    Product
    Potassium 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 Zanesvil
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1054-2015·2015-02-11

    Cardinal Health Recalls Lubricated Intubating Stylets Due to Shear Risk

    Cardinal Health is recalling 104,432 Lubricated Intubating Stylets 6FR because a small piece of the sheath may shear off during removal, posing a risk to infants and pediatric patients.

    Product
    Lubricated 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle 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) Prod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2013·2013-04-03

    Cardinal Health Recalls Needle Counters Due to Packaging Defects

    Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Mag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall covers units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA) Pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2013·2013-04-03

    Cardinal Health Recalls Needle Counters Due to Packaging Sterility Concerns

    Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0982-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Dou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0916-2013·2013-01-30

    Cardinal Health Recalls Dairy Aid Lactase Caplets Due to Labeling Error

    Cardinal Health is recalling specific lots of Dairy Aid Lactase Enzyme Supplement caplets because the packaging incorrectly lists the strength as 9,000 FCC Units instead of 3,000 FCC Units.

    Product
    Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4
    Category
    Drug
    Distribution
    2 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Cardinal Health

Healthcare company

Country
United States
Founded
1971

Official website

Source: Wikidata (Q902397), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.