Copan FLOQSwabs Recall: Sterility Issues in Clinical Samples
Copan recalls FLOQSwabs and STERILE.EO swabs due to sterility assurance failures from a contract sterilizer. These swabs may not be sterile, risking infections during clinical sampling.
Lower-risk recall
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
Contact the company
What happened, in plain English
Copan is recalling FLOQSwabs and STERILE.EO swabs used for clinical samples because the sterilization process was compromised by fraud at a contract sterilizer. This means the swabs might not be sterile, potentially causing infections if used in medical procedures. Read more at govinfonow.com/recall/62226-copan-floqswabs-recall-sterility-issues-in-clinical-samples.
Source Summary by GovInfoNow · govinfonow.com/recall/62226-copan-floqswabs-recall-sterility-issues-in-clinical-samples · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2440-2021
Cite this page
“Copan FLOQSwabs Recall: Sterility Issues in Clinical Samples.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62226-copan-floqswabs-recall-sterility-issues-in-clinical-samples. Based on FDA recall #Z-2440-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2440-2021%22&limit=1).
Why it’s dangerous
The swabs were sterilized by a contract facility (Steril Milano) that engaged in intentional fraud and data manipulation, which means the sterility assurance level of 10-6 could not be guaranteed. This risk of contamination could lead to infections during medical procedures.
Who’s affected
Healthcare professionals and labs using the recalled swabs for clinical sampling are most at risk. Patients using these swabs could face infection if the swabs are not properly sterile.
How to tell if you have this one
Check for product reference numbers like REF:501CS01, REF:20226, or REF:503CS01 on the packaging. The swabs are sold with CE0123 certification for clinical use.
- Brand
Copan- Category
Medical device
What to do — step by step
Check Product Details
Look for reference numbers such as REF:501CS01, REF:20226, or REF:503CS01 on the packaging to confirm if your swabs are recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution, including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 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-2440-2021 (July 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2440-2021 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.