Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1982-2026·Announced 2026-05-06

BD GasPak EZ CO2 Pouch System gas generating sachets underperforming

Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall affecting a laboratory diagnostic device with no reported illnesses or injuries. The hazard is performance-related (sub-specification gas production) rather than a direct safety threat, making it consistent with a moderate severity precautionary recall.

Plain-English summary

Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems for microbiologic use. The affected Catalog Number is 260684 (UDI-DI: 30382902606841), with Lot Numbers 5303157, 5329857, and 5329860. BD identified that gas generating sachets in these lots may produce carbon dioxide levels below specification, which could affect their intended laboratory use.

Approximately 25,760 units have been distributed worldwide, including throughout the US and to Hong Kong. These systems are used for microbiologic applications where precise gas composition is required for accurate laboratory results.

Healthcare facilities and laboratories using affected lots should discontinue use and contact Becton Dickinson with questions. Customers should refer to FDA Medical Device Recall Z-1982-2026 for further information.

The recalled product

Product: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — Laboratory / Microbiologic
Hazard: performance-defect
gas-generation-below-spec
Affected units: 25,760

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Catalog Nunber: 260684
UDI-DI: 30382902606841
Lot Numbers: 5303157
5329857
5329860.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Becton Dickinson & Co.

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