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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Cardinal Health Level 3 Isolation Gowns Recalled for Fluid Protection Failure

Agency Publication Date: December 11, 2024
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Summary

Cardinal Health has recalled approximately 940,203 Level 3 Isolation Gowns, including Convertor and SMS Elastic Cuff models. These gowns were manufactured using materials that may fail hydrostatic pressure specifications, meaning they might not provide the intended Level 3 fluid protection. There are currently no reports of injuries or incidents related to this issue.

Risk

If a gown fails to provide the required fluid barrier, healthcare workers or patients could be exposed to blood or other infectious bodily fluids, which increases the risk of cross-contamination and infection.

What You Should Do

  1. This recall affects Cardinal Health Convertor Isolation Gowns and SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns under several product codes including AT6100, AT6100-XL, AT6200, AT6200-XL, AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL.
  2. Identify affected products by checking the Product Code and the 14-digit UDI-DI number printed on the product labeling. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled isolation gowns immediately and quarantine any remaining inventory to prevent further use in clinical settings.
  4. Contact Cardinal Health or your medical supply distributor to arrange for the return, replacement, or correction of the gowns.
  5. Call the FDA at 1-888-463-6332 if you have additional questions regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Convertor Isolation Gown, AAMI Level 3 protection
Variants: Standard, XL
Model / REF:
AT6100
AT6100-XL
AT6200
AT6200-XL
Lot Numbers:
All Lots
UDI:
50192253048252
20192253048251
50192253048269
20192253048268
50192253048276
20192253048275
50192253048283
20192253048282

Quantity: 940,203 total units across all affected gown models.

Product: Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back
Variants: 2XL, BD, XL
Model / REF:
AT6588-2XL
AT6588-BD
AT6588-XL
AT6688-2XL
AT6688-BD
AT6688-XL
Lot Numbers:
All lots
UDI:
50885380166639
20885380166638
50885380166646
20885380166645
50885380166653
20885380166652
50885380166660
20885380166669
50885380166677
20885380166676
50885380166684
20885380166683

Quantity: 940,203 total units across all affected gown models.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95727
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Cardinal Health; Medical supply distributors
Manufactured In: United States
Units Affected: 2 products (940,203 total units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.