Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1983-2026·Announced 2026-05-06

BD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production

Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification, potentially affecting microbiologic laboratory testing.

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 of a medical device used in laboratory settings. The issue involves performance specification deviation rather than a direct hazard to patient safety, and no reported illnesses or injuries are indicated in the source text.

Plain-English summary

Becton Dickinson & Co. is recalling BD GasPak EZ Campy Pouch System (Catalog Number 260685) due to an issue affecting certain lots where gas generating sachets may produce carbon dioxide levels below specification. This product is used for microbiologic applications in laboratory settings.

The affected product has been distributed worldwide, including throughout the US and in Hong Kong. The recall involves Lot Number 5329863 (UDI-DI: 30382902606858), with approximately 2,200 units affected. Gas generating sachets that do not produce adequate carbon dioxide levels could compromise the intended function of the system in microbiologic testing.

Laboratories and healthcare facilities using this product should check their inventory for the affected lot number and contact Becton Dickinson & Co. for guidance on product replacement or proper handling.

The recalled product

Product: BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — Laboratory / Microbiologic Test System
Hazard: performance-defect
inadequate-gas-generation
Affected units: 2,200

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 (3)

Catalog Number: 260685
UDI-DI: 30382902606858
Lot Number: 5329863.

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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