CLASS II ONGOING Device recall · Reported 18 Dec 2024 · FDA Enforcement Report
Cardinal Health SMS Elastic Cuff Thumbhook Level recalled
Cardinal Health 200 is recalling Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, distributed nationwide in the US. The recall was initiated on 1 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0675-2025
- FDA event ID
- 95727
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2024
- FDA classified
- 11 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 1 Nov 2024 | Recall initiated by company | |
| 11 Dec 2024 | Classified by FDA | +40 days |
| 18 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
Where it was distributed
US Nationwide. Canada, UAE
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All lots. AT6588-2XL UDI-DI: CS (01) 50885380166639 EA (01) 20885380166638; AT6588-BD UDI-DI: CS (01) 50885380166646 EA (01) 20885380166645; AT6588-XL UDI-DI: CS (01) 50885380166653 EA (01) 20885380166652; AT6688-2XL UDI-DI: CS (01) 50885380166660 EA (01) 20885380166669; AT6688-BD UDI-DI: CS (01) 50885380166677 EA (01) 20885380166676; AT6688-XL UDI-DI: CS (01) 50885380166684 EA (01) 20885380166683
Where was it sold?
US Nationwide. Canada, UAE
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95727| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Convertor Isolation Gown, AAMI Level 3 protection recalled | Cardinal Health 200 | Other | Nationwide |
More recalls from Cardinal Health 200
All 289| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Convenience Kits: KIT, Usgpiv recalled by Cardinal Health 200 | Cardinal Health 200 | Packaging Defects | Nationwide |
Other Masks, Gloves & PPE recalls
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| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |