Halyard LAVH PACK Recall Issued by AVID Medical
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AVID Medical, Inc. is recalling 40 Halyard LAVH PACK units due to improper EO sterilization of a kit component that may cause leaking.
Reading this FDA recall beyond the headline
This notice was issued by FDA on September 8, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.", distributed us nationwide distribution in the state of 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.
A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a 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, Devices.
What Happened
AVID Medical, Inc. initiated a voluntary recall because the kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Which Products Are Affected
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907). UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027. A total of 40 packs are affected. Distribution was US Nationwide in the state of TX.
What You Should Do
Consumers should contact the recalling firm for further information regarding the recall.
Why This Matters
The Class II recall involves a device component that may leak due to improper sterilization processing.
Source
FDA recall number Z-2964-2026, event ID 99443. https://www.fda.gov
Original source: FDA Official Notice ↗
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Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Ref. 929d71)
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Elsewhere in the country: similar length or severity timing 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (831 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 8, 2026.
Common Questions
Questions readers often have about this FDA recall.