Cardinal Health Presource Procedure Packs with AAMI Level 3 Surgical Gowns Recalled Due
Cardinal Health recalls Presource Procedure Packs containing AAMI Level 3 surgical gowns produced between September 2018 and February 2020. The gowns may not be sterile, increasing surgical site infection risk. Affected kits include specific catalog numbers listed in the recall.
Lower-risk recall
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Contact the company
What happened, in plain English
Cardinal Health is recalling Presource Procedure Packs with AAMI Level 3 surgical gowns produced between September 2018 and February 2020. These gowns were manufactured without proper environmental controls, which means they may not be sterile. Using these gowns during surgery could increase the risk of surgical site infections. Read more at govinfonow.com/recall/65914-cardinal-health-presource-procedure-packs-with-aami-level-3-surgical.
Source Summary by GovInfoNow · govinfonow.com/recall/65914-cardinal-health-presource-procedure-packs-with-aami-level-3-surgical · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1235-2020
Cite this page
“Cardinal Health Presource Procedure Packs with AAMI Level 3 Surgical Gowns Recalled Due.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65914-cardinal-health-presource-procedure-packs-with-aami-level-3-surgical. Based on FDA recall #Z-1235-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2020%22&limit=1).
Why it’s dangerous
The surgical gowns were manufactured at facilities that did not maintain proper environmental conditions. This lack of control means the gowns may not be sterile. If used during surgery, they could compromise the sterile field and increase the risk of surgical site infections.
Who’s affected
Healthcare professionals and surgical teams who used the recalled Presource Procedure Packs with AAMI Level 3 surgical gowns between September 2018 and February 2020 are most at risk. The recall affects specific catalog numbers and lot codes listed in the notice.
How to tell if you have this one
Check the catalog number and lot code on the Presource Procedure Packs. Affected items include specific catalog numbers produced between September 1, 2018, and February 19, 2020, as listed in the recall notice.
- Brand
Cardinal Health- Category
Medical device
What to do — step by step
Check Your Product
Look for the catalog number and lot code on the Presource Procedure Packs. Affected items include specific catalog numbers produced between September 1, 2018, and February 19, 2020.
Contact Cardinal Health
If you have the affected product, contact Cardinal Health directly for instructions on how to return or dispose of the items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1235-2020 (January 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1235-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.