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 January 2020. The gowns may not be sterile, increasing surgical site infection risk. Check catalog numbers and lot codes listed for affected items.
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 January 2020. The gowns were manufactured without proper environmental controls, which means they may not be sterile. This could increase the risk of surgical site infections during procedures. Read more at govinfonow.com/recall/65918-cardinal-health-presource-procedure-packs-with-aami-level-3-surgical.
Source Summary by GovInfoNow · govinfonow.com/recall/65918-cardinal-health-presource-procedure-packs-with-aami-level-3-surgical · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1301-2020
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/65918-cardinal-health-presource-procedure-packs-with-aami-level-3-surgical. Based on FDA recall #Z-1301-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1301-2020%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, which could compromise the surgical field and lead to infections in patients.
Who’s affected
Healthcare professionals who use these surgical gowns during procedures are most at risk. Patients undergoing surgery with these gowns could face a higher risk of infection.
How to tell if you have this one
Check for catalog numbers and lot codes listed in the recall notice: PB08GAGHS 521235, PB08GAGHS 529320, PB08GAGHS 554815, and other specific combinations listed in the full recall details. These items were produced between September 2018 and January 2020.
- Brand
Cardinal Health- Category
Medical device
What to do — step by step
Check Product Details
Review the catalog number and lot code on the Presource Procedure Packs to confirm if they are affected. Affected items have specific catalog numbers and lot codes listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide. Chile, Israel, UAE.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
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-1301-2020 (January 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1301-2020 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.