Halyard Eye Bag Pack Recall Due to Sterilization Issue

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. is recalling 60 Halyard Eye Bag Pack kits distributed nationwide after sealed pouches were inadvertently shipped without validated sterilization.

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

This notice was issued by FDA on July 28, 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, Devices.

What Happened AVID Medical, Inc. initiated a voluntary recall after discovering that sealed pouches in the kits had not undergone validated sterilization.

Which Products Are Affected The recall involves Halyard Eye Bag Pack kits with Kit Code UIEB48-01, UDI-DI 10809160484098, Lot Number UIEB48-01, and Expiration Date 8/7/2028. A total of 60 kits were distributed in the United States, including the state of Iowa. The recall number is Z-2410-2026 and it is classified as Class II.

What You Should Do Consumers should contact AVID Medical, Inc. for return or refund instructions. The firm initiated notification via E-Mail on April 30, 2026.

Why This Matters The distribution of unsterilized medical kits poses a risk of infection to patients.

Source FDA recall number Z-2410-2026

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. is recalling 60 Halyard Eye Bag Pack kits distributed nationwide after sealed pouches were inadvertently shipped without validated sterilization.
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.