Halyard DAVINCI TRUCUSTOM BUNDLE Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
AVID Medical, Inc. is recalling 45 kits of the Halyard DAVINCI TRUCUSTOM BUNDLE due to labeling that fails to identify natural rubber latex in the StatLock component.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references Mississippi, Texas. The FDA classifies this as a Class II recall, with the stated reason "Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.", distributed us nationwide distribution in the states of ms, tx.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Medical Devices.
What Happened
The medical kit labeling fails to identify that the StatLock component contains natural rubber latex.
Which Products Are Affected
Brand Name: Halyard. Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK. Model/Catalog Number: SAMM064-27. Lot Number: 1634391. UDI: 10809160439708. Quantity: 45 kits. Distributed to MS and TX.
What You Should Do
Consumers should follow instructions provided in the recall notification from the recalling firm.
Why This Matters
This Class II recall affects medical kits distributed nationwide in Mississippi and Texas.
Source
FDA recall number Z-3005-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (713 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.