CARDINAL HEALTH AT6100Recalls & reported problems
Cardinal Health 200, LLC · Isolation Gown, Universal, Yellow · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 1, 2024Class IIOpen, Classified
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.
Z-0674-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Gown, isolation, surgical devices
- CARDINAL HEALTH AT6588-2XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6200-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6588-BDCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6588-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6688-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6688-BDCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6100-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6200Cardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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