Cardinal Health recalls Level 3 isolation gowns that may fail hydrostatic pressure tests, risking inadequate protection during medical procedures.
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 Level 3 isolation gowns that may not meet safety standards for medical use. These gowns could fail under pressure, potentially compromising patient and staff safety during procedures.
The gowns were made with materials that might not withstand hydrostatic pressure, meaning they could fail during medical procedures. This could lead to inadequate protection for both patients and healthcare workers.
Healthcare workers using these gowns for medical procedures are most at risk. The recall affects specific product codes sold through Cardinal Health.
Check for product codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, or AT6688-XL on the gown. These gowns were sold with specific UDI-DI identifiers listed in the recall notice.
Look for the product codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, or AT6688-XL on the gown.
The gowns were manufactured with materials that may fail hydrostatic pressure tests, meaning they might not meet Level 3 safety standards for medical use.
Check for product codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, or AT6688-XL on the gown.
The recall notice does not specify a remedy, so no action is required beyond checking if your gown has the listed product codes.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0675-2025 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0675-2025 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.
