Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
27,110 detailed records are currently available in this category.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
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 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 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…
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.
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).
Five warning statements are missing from the instructions for use.
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.
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).
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).
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.
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.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
