Complete FDA and NHTSA recall records dated in June 2018.
These records include useful source details for the selected month.
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per…
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.
When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated…
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.
One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial…
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 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…
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing…
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).
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.
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require…
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.
Product may fail performance testing for S aureus ATCC 43300.
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing…
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
