---
title: "Cardinal Health Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall"
description: "Search Cardinal Health recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions."
url: https://isitonrecall.com/brand/cardinal-health/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Home](https://isitonrecall.com/) / Brand archive

# Cardinal Health recall records

**17** reported ongoing

20 records in this archive. Latest source date Mar 20, 2026. 3 published notices do not supply a closure status.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## Records and reported status

Mar 20, 2026 FDA company announcement

### [Webcol: Large Alcohol Prep Pads (70% isopropyl alcohol)](https://isitonrecall.com/recall/fdapress-36aaca1e443815a9-webcol-large-alcohol-prep-pads-70-isopropyl-alcohol/)

Microbial Contamination

Not supplied Published notice; closure not supplied

Distribution: The product was distributed in the U.S., Puerto Rico and Japan between September 2025 and February 2026.

[Official source for Webcol: Large Alcohol Prep Pads (70% isopropyl alcohol)](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-voluntary-nationwide-recall-webcoltm-large-alcohol-prep-pad)

Feb 5, 2024 FDA company announcement

### [Covidien and Cardinal Health: Expanded list of Urology and OR room specific kits and trays](https://isitonrecall.com/recall/fdapress-7721107519f2216d-covidien-and-cardinal-health-expanded-list-of-urology-and-or-room-specific-kits-and-trays/)

Potential lack of sterility assurance which could result in non-sterile product

Not supplied Published notice; closure not supplied

Distribution: Not supplied

[Official source for Covidien and Cardinal Health: Expanded list of Urology and OR room specific kits and trays](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-medical-device-recall-nurse-assist-products-contained-within-kitstrays-0)

Dec 7, 2023 FDA company announcement

### [Covidien and Cardinal Health: Urology and OR room specific kits and trays](https://isitonrecall.com/recall/fdapress-7723322fc556cf4a-covidien-and-cardinal-health-urology-and-or-room-specific-kits-and-trays/)

Potential lack of sterility assurance which could result in non-sterile product

Not supplied Published notice; closure not supplied

Distribution: Not supplied

[Official source for Covidien and Cardinal Health: Urology and OR room specific kits and trays](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-medical-device-recall-nurse-assist-products-contained-within-kitstrays)

Nov 1, 2022 FDA device enforcement

### [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](https://isitonrecall.com/recall/fda-device-z-0356-2023-dover-closed-urethral-tray-with-vinyl-catheter-14-fr-ch-4-7-ml-5ml-catheter-product-code-2480-intend/)

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

Class II Reported ongoing

Distribution: Nationwide

[Official source for Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0356-2023%22)

Nov 1, 2022 FDA device enforcement

### [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](https://isitonrecall.com/recall/fda-device-z-0357-2023-dover-closed-urethral-tray-with-hydrogel-coated-red-rubber-catheter-16-fr-ch-5-3-mm-product-code-340/)

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

Class II Reported ongoing

Distribution: Nationwide

[Official source for Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Cod...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0357-2023%22)

Nov 1, 2022 FDA device enforcement

### [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](https://isitonrecall.com/recall/fda-device-z-0358-2023-dover-closed-urethral-tray-with-hydrogel-coated-red-rubber-catheter-14-fr-ch-4-7-mm-product-code-341/)

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

Class II Reported ongoing

Distribution: Nationwide

[Official source for Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Cod...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0358-2023%22)

Nov 1, 2022 FDA device enforcement

### [Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient](https://isitonrecall.com/recall/fda-device-z-0359-2023-dover-closed-urethral-tray-with-vinyl-catheter-product-code-3420-intended-for-urinary-drainage-from/)

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

Class II Reported ongoing

Distribution: Nationwide

[Official source for Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0359-2023%22)

Nov 1, 2022 FDA device enforcement

### [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 b...](https://isitonrecall.com/recall/fda-device-z-0360-2023-dover-closed-urethral-tray-with-vinyl-catheter-14-fr-ch-4-7-mm-5-ml-catheter-pre-connected-to-1000-m/)

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

Class II Reported ongoing

Distribution: Nationwide

[Official source for Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0360-2023%22)

Nov 1, 2022 FDA device enforcement

### [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...](https://isitonrecall.com/recall/fda-device-z-0361-2023-dover-closed-urethral-tray-with-vinyl-catheter-14-fr-ch-4-7-mm-5-ml-catheter-pre-connected-to-1000-m/)

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

Class II Reported ongoing

Distribution: Nationwide

[Official source for Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0361-2023%22)

Nov 2, 2021 FDA device enforcement

### [SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474](https://isitonrecall.com/recall/fda-device-z-0368-2022-smartgown-breathable-surgical-gowns-with-raglan-sleeves-x-large-x-long-a-line-sku-32474/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0368-2022%22)

Nov 2, 2021 FDA device enforcement

### [SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011](https://isitonrecall.com/recall/fda-device-z-0369-2022-smartsleeve-poly-reinforced-breathable-sleeve-surgical-gowns-large-sku-9011/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0369-2022%22)

Nov 2, 2021 FDA device enforcement

### [SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041](https://isitonrecall.com/recall/fda-device-z-0370-2022-smartsleeve-poly-reinforced-breathable-sleeve-surgical-gowns-x-large-sku-9041/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0370-2022%22)

Nov 2, 2021 FDA device enforcement

### [SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL](https://isitonrecall.com/recall/fda-device-z-0371-2022-smartsleeve-poly-reinforced-breathable-sleeve-surgical-gowns-x-large-x-long-sku-9041el/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0371-2022%22)

Nov 2, 2021 FDA device enforcement

### [Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010](https://isitonrecall.com/recall/fda-device-z-0372-2022-cardinal-health-poly-reinforced-surgical-gowns-large-sku-9010/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0372-2022%22)

Nov 2, 2021 FDA device enforcement

### [Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040](https://isitonrecall.com/recall/fda-device-z-0373-2022-cardinal-health-poly-reinforced-surgical-gowns-x-large-sku-9040/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0373-2022%22)

Nov 2, 2021 FDA device enforcement

### [Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070](https://isitonrecall.com/recall/fda-device-z-0374-2022-cardinal-health-poly-reinforced-surgical-gowns-xx-large-sku-9070/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0374-2022%22)

Nov 2, 2021 FDA device enforcement

### [RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518](https://isitonrecall.com/recall/fda-device-z-0375-2022-royalsilk-non-reinforced-surgical-gowns-large-sku-9518/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0375-2022%22)

Nov 2, 2021 FDA device enforcement

### [RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548](https://isitonrecall.com/recall/fda-device-z-0376-2022-royalsilk-non-reinforced-surgical-gowns-x-large-sku-9548/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0376-2022%22)

Nov 2, 2021 FDA device enforcement

### [RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578](https://isitonrecall.com/recall/fda-device-z-0377-2022-royalsilk-non-reinforced-surgical-gowns-xx-large-sku-9578/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0377-2022%22)

Nov 2, 2021 FDA device enforcement

### [RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998](https://isitonrecall.com/recall/fda-device-z-0378-2022-royalsilk-non-reinforced-surgical-gowns-xxx-large-x-long-sku-95998/)

Potential for open packaging seals compromising the sterility of the surgical gowns

Class II Reported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

[Official source for RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0378-2022%22)

## Reasons in these listed records

- Microbial Contamination
- Potential lack of sterility assurance which could result in non-sterile product
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Potential for open packaging seals compromising the sterility of the surgical gowns

These examples come from this result page and are not a ranking of every recall reason.

## Checking Cardinal Health

### Is there a recall on cardinal health right now?

This archive contains 20 records, including 17 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

### How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier.

### Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

### What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices.

### Where can I find older records?

Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

## Keep checking

[Search Cardinal Health](https://isitonrecall.com/check/?q=Cardinal%20Health) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)
