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Ongoing FDAEvent 99710 (23 days ago)

Cardinal Health 200 Presource Convenience Kits

Presource Convenience Kits contain applicators with open or incomplete seals, which could cause infection.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Cardinal Health 200, LLC, of Waukegan, Illinois, began a recall on August 10, 2026, of Presource Convenience Kits because the kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection.

Less commonly, systemic infection or other infectious complications may occur. The recall was added to the FDA's Enforcement Report on September 22, 2026, and distributed nationwide in the states of Florida, Kentucky, Missouri, North Carolina, Ohio and Texas.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your kit affected?

Match the list below, then check the codes the FDA notice also names.

  1. Presource Convenience Kits

    1. UDI-DI
      • 10197106721834
      • 10198956006331
      Lot
      • 4249818
      • 5124984
      • 5129488
      • 5188103
      • 5211212
      • 5155824
      • 5211985
      • 5279226
      • 5246952
      • 6062168
      • 6051588
      • 5195818
      • 5211907
      • 6037918
      • 5310701
      • 60622168
      • 4248961
      • 5248375
      • 5309623
      • 5150160
      • 5188102
      • 5350797
      • 5126398
      • 5181074
      • 5129058
      • 5210853
    2. UDI-DI
      • 10197106488959
      • 50197106488957
      Lot
      • 5126398
      • 5129488
      • 5181074
      • 5182660
      • 5188103
      • 5188102
      • 5199118
      • 5195818
      • 5150160
      • 5210853
      • 5248375
      • 5276968
      • 5350797
      • 5279226
      • 5307185
      • 5310701
      • 6051588
      • 5129058

Details

Company began the recall
Sold in

US Nationwide distribution in the states of Florida, Kentucky, Missouri, North Carolina, Ohio, Texas.

Event ID
99710
Recall numbers
Z-3254-2026 to Z-3255-2026
Company
Cardinal Health 200, LLCWaukegan, Illinois
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from Cardinal Health 200, LLC

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration