Cardinal Health
Complete recall history across all FDA and CPSC categories — 75 total recalls
Recall Summary
Cardinal Health appears in recall records across 3 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Food Recalls (1)
FDA food safety enforcement actions by Cardinal Health
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 13, 2012 | Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC... | The firm discovered that the labeling bears an incorrect strength of 9,000 FC... | Class II |
Drug Recalls (1)
FDA drug safety enforcement actions by Cardinal Health
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 2, 2013 | Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... | Labeling: Incorrect or Missing Package Insert: the package insert for the pot... | Class III |
Device Recalls (73)
FDA medical device enforcement actions by Cardinal Health. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 1, 2022 | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch ... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag whi... | Class II |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag whi... | Class II |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag whi... | Class II |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag whi... | Class II |
| Nov 1, 2022 | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch ... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag whi... | Class II |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag whi... | Class II |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-li... | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long ... | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Nov 2, 2021 | RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 | Potential for open packaging seals compromising the sterility of the surgical... | Class II |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Cod... | Potential for the plunger to draw back after the air has been expelled and re... | Class I |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code... | Potential for the plunger to draw back after the air has been expelled and re... | Class I |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code ... | Potential for the plunger to draw back after the air has been expelled and re... | Class I |
| Jan 11, 2020 | AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | ROYALSILK 2XLARGE, Gown. Item Code 9578 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | ROYALSILK XLARGE, Gown. Item Code 9548 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | ROYALSILK LARGE, Gown. Item Code 9518 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 | The gowns contain an unknown level of bioburden, unknown microbiological flor... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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