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.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while…
Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate…
Communication-connection error.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is…
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is…
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as…
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
The product was mislabeled with the incorrect label.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as…
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a 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.
