Cardinal Health recalls AAMI Level 3 isolation gowns with product codes AT6100, AT6100-XL, AT6200, and AT6200-XL due to potential hydrostatic pressure failure. These gowns may not meet required protection standards.
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Cardinal Health is recalling isolation gowns that may fail hydrostatic pressure tests, meaning they might not provide the required Level 3 protection against pathogens. This could lead to inadequate protection during medical procedures.
The gowns were made with materials that may not withstand hydrostatic pressure, which is critical for maintaining protection during medical procedures. This could mean the gowns fail to prevent pathogen transmission when used in high-risk environments.
Healthcare workers using these gowns for medical procedures are most at risk. Patients receiving care during procedures using recalled gowns could also be affected.
Check for product codes AT6100, AT6100-XL, AT6200, or AT6200-XL on the gown. All lots are affected, so any gown with these codes should be considered recalled.
Look for product codes AT6100, AT6100-XL, AT6200, or AT6200-XL on the gown label.
The recall states these gowns may not meet required hydrostatic pressure standards, so they are not safe for use in medical procedures.
Check for product codes AT6100, AT6100-XL, AT6200, or AT6200-XL on the gown label.
The recall does not specify a remedy, so contact Cardinal Health directly for guidance.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0674-2025 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0674-2025 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
