Complete FDA and NHTSA recall records dated in June 2019.
These records include useful source details for the selected month.
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states…
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Audi Q5 and SQ5 vehicles. In the event of a crash deploying the passenger's frontal air bag, the instrument panel…
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 trucks. The spare tire provided may differ in size and required inflation pressure from the information on the tire placard label.…
Chrysler (FCA US LLC) is recalling certain 2019 Jeep Cherokee vehicles. The impact and acceleration sensors may fail and reduce the air bag system's ability to properly detect certain crash…
The heated tube sets were consistently leaking and detaching from the cassette.
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
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…
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
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…
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
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 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…
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 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…
The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
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…
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.
