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Lower risk Medical device recall · FDA · Published July 28, 2017

Cardinal Health Robotic Drape Recall: Wrong Packaging Causes Confusion

Cardinal Health recalls robotic drapes with incorrect packaging labels that may cause confusion during medical procedures. Affected units include Lot 17DAH349.

🇺🇸 FDA recall #Z-3046-2017Medical deviceCardinal Health ›
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Recalling firmCardinal Health 200, LLC1500 S Waukegan Rd · Waukegan, IL 60085-6728
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling robotic drapes that were incorrectly labeled as 'Robotic Drape with Leggings' when they were actually single sterile drapes. This confusion could lead to improper use in medical settings. Read more at govinfonow.com/recall/73335-cardinal-health-robotic-drape-recall-wrong-packaging-causes-confusion.

Source Summary by GovInfoNow · govinfonow.com/recall/73335-cardinal-health-robotic-drape-recall-wrong-packaging-causes-confusion · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3046-2017

Cite this page

“Cardinal Health Robotic Drape Recall: Wrong Packaging Causes Confusion.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73335-cardinal-health-robotic-drape-recall-wrong-packaging-causes-confusion. Based on FDA recall #Z-3046-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3046-2017%22&limit=1).

Why it’s dangerous

The drape was mislabeled as a robotic drape with leggings when it's actually a single sterile drape. This could cause confusion during medical procedures if healthcare workers use the wrong type of drape.

Who’s affected

Healthcare facilities using these drapes for surgical procedures are most at risk. Patients and staff may be affected if the wrong drape is used during surgery.

How to tell if you have this one

Check for the lot number 17DAH349 on the packaging. The product is sold as single sterile drapes packaged 8 per case.

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

What to do — step by step

  1. Check Packaging

    Look for the lot number 17DA:349 on the packaging to identify affected units.

Where it went and when

Where it was distributed

Distributed in 8 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Georgia, New Jersey, New York, North Carolina, Oregon, Texas, Utah.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Jul 28, 201712. FDA classified it Class II: Aug 21, 201723. Published in FDA’s Enforcement Report: Aug 30, 201734. FDA terminated the recall: Dec 26, 201742017
  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.

✎ GovInfoNow

Questions people ask

Is there a risk of injury from this drape?

The recall is for labeling confusion, not a safety hazard. There is no risk of injury from improper use.

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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-3046-2017 (July 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3046-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on September 20, 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