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Lower risk Medical device recall · FDA · Published May 2, 2025

Copan Italia CultureSwab EZ System Recall: Swabs May Break During Use

Copan Italia recalls BD BBL CultureSwab EZ Collection and Transport System (REF 220144) due to risk of swab breakage during specimen collection. This in vitro diagnostic product requires immediate attention for safety.

🇺🇸 FDA recall #Z-1937-2025Medical deviceCopan Italia ›
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Recalling firmCopan ItaliaVia Francesco Perotti 10, 18 · Brescia, Italy
✎ GovInfoNow plain-language explainer

What happened, in plain English

Copan Italia is recalling its BD BBL CultureSwab EZ Collection and Transport System (REF : 220144) because swabs may break during use. This could lead to specimen collection issues or potential contamination risks for medical testing. Read more at govinfonow.com/recall/52351-copan-italia-cultureswab-ez-system-recall-swabs-may-break-during.

Source Summary by GovInfoNow · govinfonow.com/recall/52351-copan-italia-cultureswab-ez-system-recall-swabs-may-break-during · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1937-2025

Cite this page

“Copan Italia CultureSwab EZ System Recall: Swabs May Break During Use.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52351-copan-italia-cultureswab-ez-system-recall-swabs-may-break-during. Based on FDA recall #Z-1937-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1937-2025%22&limit=1).

Why it’s dangerous

The swabs may break during product usage, which could lead to specimen collection issues or potential contamination risks. This breakage might affect the accuracy of medical testing results.

Who’s affected

Healthcare professionals and labs using this in vitro diagnostic product for specimen collection are most at risk. Patients and providers using the system for medical testing may be affected.

How to tell if you have this one

Check for the product name 'BD BBL CultureSwab EZ Collection and Transport System' with reference number 220144. This in vitro diagnostic product is sold with a sterile packaging and requires a prescription (Rx Only).

  • Brand
    Copan Italia
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name and reference number 220144 to confirm if you have the recalled item.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of MD.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: May 2, 202512. FDA classified it Class II: Jun 9, 202523. Published in FDA’s Enforcement Report: Jun 18, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a risk of swab breakage during use, but the product is still considered safe for general use unless breakage occurs.

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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-1937-2025 (May 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1937-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA