Complete FDA and NHTSA recall records dated in April 2020.
These records include useful source details for the selected month.
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create…
The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola…
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to…
Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap…
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to…
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false…
If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to…
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to…
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap…
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
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.
