Complete FDA and NHTSA recall records dated in May 2019.
These records include useful source details for the selected month.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Several lots of Jelco ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the…
Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result…
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
2.5 Truliant Fit Trays were mismarked as 3
There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam…
The bone screw is shorter than the intended design specification.
Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
Sterilization method used was not consistent with the labeling and the approved sterilization method
Devices may generate excessive heat during use.
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Sterilization method used was not consistent with the labeling and the approved sterilization method
Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to…
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without…
Sterilization method used was not consistent with the labeling and the approved sterilization method
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Small black plastic particle was observed in the left ventricle during implant procedure.
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s…
Banana Puddin Base contains an undeclared egg sub-ingredient.
Products are labeled gluten free but have been found to contain gluten in excess of 20 ppm in finished products.
Product's ingredients statement declared cheese but label did not declare milk.
Products are labeled gluten free but have been found to contain gluten in excess of 20 ppm in finished products.
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.
