PlainRecalls

Cardinal Health

Compiled from official public sources by the editorial team.

75 recalls on record · Latest: Dec 14, 2022

Cardinal Health Recall Insight

Cardinal Health appears on 75 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.074% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 14, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 3 critical, 47 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 12, 2020 to Dec 14, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 14, 2022

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…

FDA Devices Moderate Dec 14, 2022

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 b…

FDA Devices Moderate Dec 14, 2022

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…

FDA Devices Moderate Dec 14, 2022

Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient

FDA Devices Moderate Dec 14, 2022

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 Intend…

FDA Devices Moderate Dec 14, 2022

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 bla…

FDA Devices Moderate Dec 22, 2021

RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548

FDA Devices Moderate Dec 22, 2021

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

FDA Devices Moderate Dec 22, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

FDA Devices Moderate Dec 22, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041

FDA Devices Moderate Dec 22, 2021

Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010

FDA Devices Moderate Dec 22, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

FDA Devices Moderate Dec 22, 2021

RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578

FDA Devices Moderate Dec 22, 2021

Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070

FDA Devices Moderate Dec 22, 2021

SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474

FDA Devices Moderate Dec 22, 2021

Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040

FDA Devices Moderate Dec 22, 2021

RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998

FDA Devices Critical Sep 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing comp…

FDA Devices Critical Sep 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing com…

FDA Devices Critical Sep 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing co…

FDA Devices Moderate Feb 12, 2020

AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB

FDA Devices Moderate Feb 12, 2020

AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

FDA Devices Moderate Feb 12, 2020

AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541

FDA Devices Moderate Feb 12, 2020

AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515

FDA Devices Moderate Feb 12, 2020

AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB

FDA Devices Moderate Feb 12, 2020

ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N

FDA Devices Moderate Feb 12, 2020

ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998

FDA Devices Moderate Feb 12, 2020

AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545

FDA Devices Moderate Feb 12, 2020

ROYALSILK LARGE, Gown. Item Code 9518

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA

FDA Devices Moderate Feb 12, 2020

ROYALSILK XLARGE, Gown. Item Code 9548

FDA Devices Moderate Feb 12, 2020

GOWN SURG LG W/TOWEL ST BACK, Item Code 9515

FDA Devices Moderate Feb 12, 2020

AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585

FDA Devices Moderate Feb 12, 2020

AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545

FDA Devices Moderate Feb 12, 2020

AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC

FDA Devices Moderate Feb 12, 2020

AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC

FDA Devices Moderate Feb 12, 2020

AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511

FDA Devices Moderate Feb 12, 2020

AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB

FDA Devices Moderate Feb 12, 2020

AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541

FDA Devices Moderate Feb 12, 2020

AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575

FDA Devices Moderate Feb 12, 2020

AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL

FDA Devices Moderate Feb 12, 2020

AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB

FDA Devices Moderate Feb 12, 2020

ROYALSILK 2XLARGE, Gown. Item Code 9578

FDA Devices Moderate Feb 12, 2020

AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Cardinal Health with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.