Class 2 Device Recall BD GasPak EZ CO2 Pouch System

• Date Initiated by Firm: April 07, 2026
• Date Posted: April 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1982-2026
• Recall Event ID: 98657
• Product Classification: Device, gas generating - Product Code KZJ
• Product: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
• Code Information: Catalog Nunber: 260684; UDI-DI: 30382902606841; Lot Numbers: 5303157, 5329857, 5329860.
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: 410-316-4000
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 04/07/2026, BD sent URGENT: Medical Device Correction letters to customers and distributors. Consignees were instructed that there are no recommendations for retrospective chart review or repeat patient testing. They are to verify incubation atmospheres by incorporating the use of appropriate gas indicators as part of routine laboratory quality control practices. Each BD GasPak EZ Gas Generating Pouch System should be tested periodically for its ability to provide adequate conditions for the growth of target organisms. For CO2 incubation, laboratories may use BD CO2 Indicators (Catalog No. 271055), along with the impacted catalog 260684, to verify sufficient CO2 presence in the environment. If conditions are not confirmed or are suspected to be out of specification, laboratories should repeat incubation using alternative validated methods or established laboratory procedures to ensure organism recovery. Additionally, consignees were instructed to ensure the contents of the notification are read and understood, share this notification with the facility network and forward it to any customers to whom product may have been distributed, and complete and return the Customer Response Form. Distributors were instructed to ensure the notification is read and understood, identify all customers that purchased any affected product, and provide a copy of the attached customer letter to all customers who received the affected lots to advise them of this Product Advisory on BD's behalf. BD is investigating the root cause and will implement appropriate corrective actions to prevent recurrence of this issue. BD GasPak catalog numbers 260684 and 260685 are currently on backorder due to seal integrity challenges identified in some batches following a recent overhaul of supplier manufacturing equipment. BD anticipates resumption of product shipments by the end of March 2026, with full recovery expected by June 2026.
• Quantity in Commerce: 25,760 units
• Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.