AVID Medical, Inc. Recalls Halyard TRANSPORT BAG KIT Over Potential Sterility Compromise

Source: FDA · New Jersey

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AVID Medical, Inc. has issued a voluntary recall for 1,500 Halyard TRANSPORT BAG KIT units due to a Tyvek bag seal issue that may compromise the sterility of the medical kit.

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

This notice was issued by FDA on February 25, 2026 and geographically references New Jersey. 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

AVID Medical, Inc. has initiated a voluntary recall of the Halyard TRANSPORT BAG KIT. The recall was triggered by the discovery of a Tyvek bag seal issue. This defect is significant as it may compromise the sterility of the medical kit, potentially exposing the contents to environmental contaminants.

Which Products Are Affected

The recall affects 1,500 units of the following medical device:

  • Product Name: Halyard TRANSPORT BAG KIT
  • Kit Code: LIFE0080-01
  • UDI-DI: 10809160314500
  • Lot Number: 1650056
  • Expiration Date: 07/24/2028

The distribution of these units was concentrated in the state of New Jersey.

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (1650056). AVID Medical, Inc. initiated notification to customers via e-mail on January 2, 2026. If you possess the recalled kits, you should follow the instructions provided in the firm's notification. For further information or to coordinate returns, contact AVID Medical, Inc. at their facility located at 9000 Westmont Dr, Toano, VA 23168-9351.

Why This Matters

Sterility is critical for medical transport kits to ensure patient safety. A compromised seal on the packaging can allow bacteria or other contaminants to enter the kit, increasing the risk of infection or complications during medical procedures.

Source

This information is based on official recall data provided by the FDA (Recall Number: Z-1338-2026).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
AVID Medical, Inc. has issued a voluntary recall for 1,500 Halyard TRANSPORT BAG KIT units due to a Tyvek bag seal issue that may compromise the sterility of the medical kit.
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 New Jersey. 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.