Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to…
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Five warning statements are missing from the instructions for use.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux…
Five warning statements are missing from the instructions for use.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux…
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
