Skip to content
Lower risk Medical device recall · FDA · Published July 30, 2020

Cardinal Health Preop Kit Recalled: Only 1 Nasal Swab Instead of 4

Cardinal Health recalls preoperative kits that contain only one nasal swab instead of four, risking incomplete treatment of nasal staph infections.

🇺🇸 FDA recall #Z-3016-2020Medical deviceCardinal Health ›
Take action

Contact the company

Recalling firmCardinal Health 200, LLC785 Fort Mill Hwy · Fort Mill, SC 29707-7555
✎ GovInfoNow plain-language explainer

Cardinal Health is recalling preoperative kits that include only one nasal swab instead of the required four swabs for proper treatment of nasal staph infections. This could lead to incomplete decolonization and increased risk of infection. Read more at govinfonow.com/recall/64587-cardinal-health-preop-kit-recalled-only-1-nasal-swab-instead.

Source Summary by GovInfoNow · govinfonow.com/recall/64587-cardinal-health-preop-kit-recalled-only-1-nasal-swab-instead · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3016-2020

Cite this page

“Cardinal Health Preop Kit Recalled: Only 1 Nasal Swab Instead of 4.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64587-cardinal-health-preop-kit-recalled-only-1-nasal-swab-instead. Based on FDA recall #Z-3016-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3016-2020%22&limit=1).

Cardinal Health 200, LLC voluntarily recalled KIT, PRE OP DRAH preoperative kits on July 30, 2020, because they contained only one nasal swab instead of the four required for proper treatment. The Food and Drug Administration announced the Class II recall.

How to tell if you have it

  • Brand: Cardinal Health
  • Product: KIT, PRE OP DRAH
  • Model: ORPDH5994A
  • Lot numbers: 558357, 561502, 566549, 571467, 574058
  • Quantity: 9,150 kits

The hazard

The recall hazard stems from providing only one nasal swab in the pre-operative kit rather than the four required for proper treatment to decolonize intranasal S. aureus.

Context

GovInfoNow's records show Cardinal Health 200, LLC has had 59 other recalls on record since 2017-06-27. Other recent recalls include the Presource Packs with Microstream Components risk of delayed treatment (2026-08-19), the Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets recall (2026-08-18), and the Cardinal Health Presource Convenience Kits recall regarding contaminated applicators (2026-08-10). Other recent recalls of similar products include the Windstone Medical Preop Kit-NS recall (2026-05-21) and the Medline Convenience Kits recalls (2026-01-07).

How to tell if you have this one

Check for model number ORPDH5994A on the kit. Lot numbers 558357, 561502, 566549, 571467, or 574058 are affected. These kits were sold with varying expiration dates.

  • Brand
    Cardinal Health
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Model

    Look for model number ORPDH5994A on the kit.

  2. Verify Lot Numbers

    Check if your kit has lot numbers 558357, 561502, 566549, 571467, or 574058.

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 including the state of North Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Jul 30, 202012. FDA classified it Class II: Sep 25, 202023. Published in FDA’s Enforcement Report: Oct 7, 202034. FDA terminated the recall: Apr 28, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

Similar recalls

Other Cardinal Health recalls

Latest medical device recalls

Keep exploring

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-3016-2020 (July 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3016-2020 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.
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