HIGHFDA DEVICE

Cardinal Health Recalls ChemoPlus Gowns Over Expiration Date Error

Cardinal Health 200 recalled 251,165 ChemoPlus gowns on November 12, 2025, due to incorrect expiration dates. The gowns are mislabeled with a five-year shelf life instead of the correct three years. Patients and healthcare providers must stop using these gowns immediately.

Official notice
Cardinal Health 200Health & Personal CareMedical DevicesProduct Code Lot # UDI-DI (GTIN): CT5500T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN045 CS- 50885380172371 EA- 20885380172370CT5502T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN044 CS 50885380172395 EA - 20885380172394CT5503T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN036 CS 50885380172418 EA - 20885380172417

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 12, 2025
Status
ACTIVE
Severity
7/10

Quick Facts at a Glance

Recall Date
November 12, 2025
Hazard Level
HIGH
Brand
Cardinal Health 200
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Cardinal Health 200
Product type
Protective Gown
Model numbers
Product Code Lot # UDI-DI (GTIN): CT5500T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN045 CS- 50885380172371 EA- 20885380172370, CT5502T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN044 CS 50885380172395 EA - 20885380172394, CT5503T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN036 CS 50885380172418 EA - 20885380172417, CT5504T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22EASN004 CS- 50885380172432 EA- 20885380172431, CT5505T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN043 CS- 50885380172456 EA- 20885380172455, DP5001GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN033 CS- 50885380173989 EA-20885380173988, DP5002GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22EASN020 CS- 50885380173996 EA-20885380173995, DP5003GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN020 CS- 50885380173972 EA-20885380173971 +11 more
Colors
Medium Blue
Sizes
Medium, Large, Extra Large, Extra Extra Large
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    November 12, 2025

  2. Reported by FDA DEVICE

    December 17, 2025

  3. RecallRadar source check

    December 24, 2025

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter

About This Product

ChemoPlus gowns are protective garments used primarily in healthcare settings to shield against chemicals and biological hazards. They are critical for patients undergoing chemotherapy and healthcare providers to ensure safety during treatment procedures.

Why This Is Dangerous

The gowns have an incorrect expiration date on the packaging, which may lead users to believe they are still effective after the actual shelf life has expired. Using expired gowns can compromise safety and protection.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face safety risks if they continue to use the affected gowns, as they may not provide adequate protection. The recall requires immediate action to avoid potential harm.

Practical Guidance

How to identify if yours is affected

  1. Locate the product code on the gown packaging.
  2. Check the expiration date on the packaging to see if it is labeled as five years instead of three years.
  3. Verify the gown size and type against the recalled product list.

Where to find product info

Product codes can typically be found printed on the packaging or labels attached to the gowns.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document your communication attempts with Cardinal Health.
  • Contact your healthcare provider for assistance if you do not receive a response.

How to prevent similar issues

  • When purchasing protective gowns, check for proper labeling and expiration dates.
  • Consider purchasing from reputable suppliers with a good safety record.
  • Look for gowns that are compliant with industry safety standards.

Documentation advice

Keep receipts, correspondence with the manufacturer, and photos of the gown and packaging as records.

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Product Details

The recall includes the following product codes: CT5500T, CT5502T, CT5503T, CT5504T, CT5505T, DP5001GT, DP5002GT, DP5003GT, and DP5004GT. The gowns were distributed worldwide, including the U.S. and Canada, and are non-sterile and sterile versions in various sizes.

Key Facts

  • Recall date: November 12, 2025
  • Quantity recalled: 251,165 units
  • Classification: Class II
  • Incorrect expiration date on packaging
  • Affected products distributed worldwide

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Product Code Lot # UDI-DI (GTIN): CT5500T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN045 CS- 50885380172371 EA- 20885380172370
CT5502T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN044 CS 50885380172395 EA - 20885380172394
CT5503T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN036 CS 50885380172418 EA - 20885380172417
CT5504T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22EASN004 CS- 50885380172432 EA- 20885380172431
CT5505T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN043 CS- 50885380172456 EA- 20885380172455
+14 more
Affected States
ALL
Report Date
December 17, 2025
Recall Status
ACTIVE

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