Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 22 recalls
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
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 the manometer port being blocked rendering the manometer non-functional.
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.