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Lower risk Medical device recall · FDA · Published January 30, 2023

Carefusion Genesis Reusable Sterilization Containers May Contaminate Surgical Equipment

Carefusion recalls CD5 Series Genesis Reusable Rigid Sterilization Containers due to potential sterility breaches. These containers may hold surgical equipment that becomes contaminated after expiration.

🇺🇸 FDA recall #Z-1236-2023Medical deviceCarefusion ›
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Recalling firmCarefusion 2200 Inc75 N Fairway Dr · Vernon Hills, IL 60061-1845
✎ GovInfoNow plain-language explainer

Carefusion is recalling 28 models of Genesis Reusable Rigid Sterilization Containers because they failed sterility testing. Using these containers could lead to contaminated surgical equipment, risking infection during procedures. Read more at govinfonow.com/recall/58994-carefusion-genesis-reusable-sterilization-containers-may-contaminate-surgical-equipment.

Source Summary by GovInfoNow · govinfonow.com/recall/58994-carefusion-genesis-reusable-sterilization-containers-may-contaminate-surgical-equipment · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1236-2023

Cite this page

“Carefusion Genesis Reusable Sterilization Containers May Contaminate Surgical Equipment.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58994-carefusion-genesis-reusable-sterilization-containers-may-contaminate-surgical-equipment. Based on FDA recall #Z-1236-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1236-2023%22&limit=1).

Carefusion 2200 Inc recalled its CD5 Series of Genesis Reusable Rigid Sterilization Container Systems because they failed shelf-life testing, potentially breaching sterility for surgical equipment, according to the FDA on Jan. 30, 2023.

How to tell if you have it

  • Brand: Carefusion
  • Product: CD5 Series of Genesis Reusable Rigid Sterilization Container Systems
  • Catalog numbers: CD5-3B, CD5-3C, CD5-61B, CD5-61C (including BLACK, BLUE, GOLD, GREEN, PURPLE, RED variants)
  • All lot numbers involved
  • Units affected: 5,952 devices

The hazard

The product did not meet shelf-life testing requirements, resulting in a breach of the sterility of the Genesis container holding surgical equipment.

Context

GovInfoNow's records show Carefusion 2200 Inc has issued eight other recalls since Dec. 20, 2013. Recent Carefusion recalls include an endoscopic grasper recall on July 13, 2023, due to cracking risks, and a vaginal specula recall on March 16, 2023, involving label mismatches. Other recent recalls of similar products include Medline Convenience Kits (Jan. 7, 2026) and Medline Surgical Packs (Jan. 7, 2026).

How to tell if you have this one

Check for the CD5-3B, CD5-3C, CD5-61B, or CD5-61C container models with specific colors or solid bottoms. All lot numbers are affected, as listed in the recall notice.

  • Brand
    Carefusion
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Container Model

    Identify the model number on the container (e.g., CD5-3B, CD5-3C) and color or bottom type to confirm if it's recalled.

  2. Contact Carefusion

    Reach out to Carefusion for guidance on next steps, as the recall includes all lot numbers and specific models.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: yesFLPuerto Rico: yesPR

FDA distribution: “Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia,…” 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 published this recall 44 days after the firm started it.

1. Firm started the recall: Jan 30, 202312. FDA classified it Class II: Mar 9, 202323. Published in FDA’s Enforcement Report: Mar 15, 202332023
  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.

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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-1236-2023 (January 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1236-2023 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