Reported Sep 2, 2026 · Ongoing · Updated Sep 7, 2026
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number:…
AVID Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AVID Medical, Inc. · 9000 Westmont Dr · Toano, VA · 23168-9351
Is this the product you have?
- Brand NameHalyard
- Product NameDAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR
- W/STATLOCK Model/Catalog NumberSAMM064-27
- Lot codes and dates
- Lot CodeLot
- Number1634391
- UDI10809160439708
- Amount recalled
- 45 kits
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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