Halyard STANDARD LINE INSERTION PACK Recall

Source: FDA · United States

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. recalls 112 Halyard STANDARD LINE INSERTION PACK kits due to silicone seal defects that may cause fluid occlusion or leakage.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. 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-device.

What Happened

Defects in the silicone seal may result in "doming" due to improper sealing, potentially leading to fluid occlusion or leakage.

Which Products Are Affected

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026). 112 kits. Distributed in the U.S. Nationwide distribution in the state of California.

What You Should Do

Contact the recalling firm AVID Medical, Inc. for return or refund instructions.

Why This Matters

The Class II recall addresses potential fluid management issues in medical convenience kits.

Source

FDA recall number Z-2772-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
AVID Medical, Inc. recalls 112 Halyard STANDARD LINE INSERTION PACK kits due to silicone seal defects that may cause fluid occlusion or leakage.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.