The FDA has posted 13 enforcement recalls from Becton Dickinson & Co. since 2025, none of them Class I (most serious). Most recent report: May 6, 2026.
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.
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.
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
Firm name as filed with the FDA: “Becton Dickinson & Co.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.