Complete FDA and NHTSA recall records dated in June 2019.
These records include useful source details for the selected month.
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Certain lots were mislabeled with incorrect product number.
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in…
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample…
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may…
Product with incorrect shelf life.
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Incorrect needle length and gage.
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in…
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect…
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
User may suffer an electric shock when coming in contact with the exposed electronic components
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
The titanium implant has the wrong article number laser marked on it.
Product with incorrect shelf life.
Certain lots were mislabeled with incorrect product number.
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Packaged with an incorrect size inner cannula.
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.
