Cardinal Health Tiburon Arthroscopy Drape Recall: Label Mismatch Risk
Cardinal Health recalls some Tiburon Arthroscopy Drapes due to mismatched labels between product and packaging. Affected units have specific lot numbers and may not be sterile. Consumers should contact Cardinal Health for details.
Lower-risk recall
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
Contact the company
What happened, in plain English
Cardinal Health is recalling certain Tiburon Arthroscopy Drapes because the labels on some units don't match the actual drape inside. This mismatch could lead to improper use of the drape, which is critical for surgical procedures. Read more at govinfonow.com/recall/73550-cardinal-health-tiburon-arthroscopy-drape-recall-label-mismatch-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73550-cardinal-health-tiburon-arthroscopy-drape-recall-label-mismatch-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-2758-2017
Cite this page
“Cardinal Health Tiburon Arthroscopy Drape Recall: Label Mismatch Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73550-cardinal-health-tiburon-arthroscopy-drape-recall-label-mismatch-risk. Based on FDA recall #Z-2758-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2758-2017%22&limit=1).
Why it’s dangerous
The drape's label does not match the product inside, which could mean it's not sterile or the wrong type of drape is used. This mismatch might lead to infection risks during surgery if the drape isn't properly sterilized.
Who’s affected
Surgical teams and hospitals that use these drapes for procedures are most at risk. Patients and staff using the recalled drapes may face complications if the drape isn't properly sterilized.
How to tell if you have this one
Check for lot numbers 16LFS235 (product 8482) or 16LUS317 (product 9414) on the label. The drape is sold as a sterile surgical product with an expiration date of November 1, 2021.
- Brand
Cardinal Health- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution - US (Nationwide including PR) and Canada
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2757-2017 | Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.; Lot 16LFS235, expires November 1, 2021 | 1591 each |
| Z-2758-2017 | Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.; Lot 16LUS317, expires November 1, 2021 | 528 each |
What to do — step by step
Check Label
Look for lot numbers 16LFS235 or 16LUS317 on the drape's label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (Nationwide including PR) and Canada” 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 terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this drape safe to use?
The drape may not be sterile if the label doesn't match, so it's not safe for surgical use without verification.
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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-2758-2017 (June 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2758-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.