Food, drugs, devices › Becton Dickinson & Co.
Device recall: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Becton Dickinson & Co. (Sparks, MD) initiated this device recall on 7 Apr 2026; FDA lists 2 product records under event 98657, classified Class II.
FDA defines Class II as 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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Becton Dickinson & Co. has 77 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Becton Dickinson & Co., Sparks, MD.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1982-2026 | BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use | 25,760 units | Class II | Ongoing | 6 May 2026 |
| Z-1983-2026 | BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use | 2,200 units | Class II | Ongoing | 6 May 2026 |
Context
Other enforcement events for Becton Dickinson & Co.
All 77 events for Becton Dickinson & Co.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the country of Hong Kong."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.