Recall of BD GasPak EZ CO2 Pouch System Due to Low Carbon Dioxide Levels

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.

Becton Dickinson & Co. is recalling 25,760 units of the BD GasPak EZ CO2 Pouch System because certain lots may produce carbon dioxide levels below specification, affecting their intended use.

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

This notice was issued by FDA on May 13, 2026 and geographically references United States. Its severity classification of "low" 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 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Becton Dickinson & Co. has initiated a voluntary recall for certain lots of the BD GasPak EZ CO2 Pouch System due to an issue where gas generating sachets may produce carbon dioxide levels below specification.

Which Products Are Affected

The affected products are the BD GasPak EZ CO2 Pouch System with Catalog Number: 260684, UDI-DI: 30382902606841, and Lot Numbers: 5303157, 5329857, 5329860. A total of 25,760 units are involved, distributed nationwide in the United States and to Hong Kong.

What You Should Do

Consumers should check if they have products with the specified catalog number and lot numbers, and contact Becton Dickinson & Co. via the initial notification letter for instructions on returns or refunds.

Why This Matters

This recall involves medical devices used for microbiologic purposes, which could affect test accuracy due to suboptimal carbon dioxide levels, though the overall impact on health is classified as Class II with potentially reversible consequences.

Source

This recall information is from the FDA with recall number Z-1982-2026. For more details, refer to the FDA website.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Becton Dickinson & Co. is recalling 25,760 units of the BD GasPak EZ CO2 Pouch System because certain lots may produce carbon dioxide levels below specification, affecting their intended use.
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 "low" severity. No immediate action required, but stay aware.
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.