Recall Z-1982-2026 ยท KZJ Device, Gas Generating
Becton Dickinson & Co.
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
| Date | Apr 29, 2026 (initiated Apr 7, 2026) |
| Status | Open, Classified |
| 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 may produce carbon dioxide levels below specification. |
| Root 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. |
| Quantity | 25,760 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.