BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Summary
The FDA issued a Class II for BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use by Becton Dickinson & Co.. Reason: BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets ma.
Details
Source
Device Recall
External ID
Z-1982-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Lot/Code Info: Catalog Nunber: 260684; UDI-DI: 30382902606841; Lot Numbers: 5303157, 5329857, 5329860.
Quantity Affected: 25,760 units
Reason for Recall
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Distribution
Worldwide distribution - US Nationwide and the country of Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-07
Company
Sparks, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Co. have FDA actions?
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1982-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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