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.

1–25 of 75

  • HighFDA (Devices)·Z-0361-2023·2022-12-14

    Dover Urinary Catheter Drainage Bag Port Occlusion Recall

    Cardinal Health is recalling Dover closed urethral catheter trays due to potential occlusion of the drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2023·2022-12-14

    Dover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Catheter Trays due to potential blockage of the urinary drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.

    Product
    Dover 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 patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2023·2022-12-14

    Dover Urinary Catheter Drainage Tray Recall Due to Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2023·2022-12-14

    Dover Urethral Catheter Drainage System Recall for Potential Port Blockage

    Cardinal Health is recalling Dover closed urethral catheter trays because the drainage bag port may become occluded, preventing urine from draining properly and increasing the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2023·2022-12-14

    Dover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk

    Cardinal Health recalls Dover Closed Urethral Tray due to potential blockage of the urinary drainage bag inlet port that could prevent urine drainage and increase risk of urinary retention if bladders are not emptied timely.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2023·2022-12-14

    Dover urinary catheter drainage bag occlusion defect nationwide recall

    Cardinal Health is recalling Dover urinary catheter trays due to potential blockage of the drainage bag inlet port, which may prevent urine drainage and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2022·2021-12-22

    SmartGown Breathable Surgical Gowns recalled for packaging seal defects

    Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.

    Product
    SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Packaging Seal Defects

    Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2022·2021-12-22

    RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling 270,839 units of RoyalSilk Non-Reinforced Surgical Gowns (X-large, SKU 9548) due to potential packaging seal failures that could compromise sterility.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2022·2021-12-22

    Surgical Gowns Recalled Due to Potential Packaging Seal Defects

    Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2022·2021-12-22

    Surgical gowns recalled due to potential compromised sterility from packaging seals

    Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2022·2021-12-22

    Cardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals

    Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential for open packaging seals that could compromise sterility. The recalled units were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2022·2021-12-22

    Cardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect

    Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals

    Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise

    Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2285-2021·2021-09-01

    Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk

    Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2286-2021·2021-09-01

    Sodium Chloride Flush Syringe Recalled Due to Plunger Malfunction Risk

    Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2284-2021·2021-09-01

    Monoject flush syringe recall: plunger may reintroduce air into IV lines

    Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.

    Product
    Monoject 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1003-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    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 GOWN 2XL BNS, Item Code 9575NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1016-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    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 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1011-2020·2020-02-12

    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 SURGGOWN BNS L, Gown. Item Code 9518NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1035-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    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 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1004-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

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

    Product
    AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.