Complete FDA and NHTSA recall records dated in October 2020.
These records include useful source details for the selected month.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the…
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a…
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the…
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the…
VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display
There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Aflatoxin level slightly above actionable limit
Routine NY Agriculture and Markets inspection found pasteurization temperature was not recorded for two lots of cheese due to pasteurizer recorder chart malfunction.
Routine NY Agriculture and Markets inspection found pasteurization temperature was not recorded for two lots of cheese due to pasteurizer recorder chart malfunction.
Routine NY Agriculture and Markets inspection found pasteurization temperature was not recorded for two lots of cheese due to pasteurizer recorder chart malfunction.
Routine NY Agriculture and Markets inspection found pasteurization temperature was not recorded for two lots of cheese due to pasteurizer recorder chart malfunction.
Routine NY Agriculture and Markets inspection found pasteurization temperature was not recorded for two lots of cheese due to pasteurizer recorder chart malfunction.
Undeclared soy (whole edamame beans)
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
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.
