Complete FDA and NHTSA recall records dated in May 2021.
These records include useful source details for the selected month.
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No…
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No…
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its…
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No…
VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated…
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No…
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its…
Products have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Products have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Bueno Coffee Substitute Creamy Hazelnut product contains undeclared hazelnut and peanut.
SnoBalls snack cakes were packaged with a label for Chocolate CupCakes causing the product to fail to declare the major food allergen coconut.
Products have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Products have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Failure to manufacture product in accordance with 21CFR part 114: Acidified Foods
Products have the potential to be contaminated with Salmonella. The cashew cheese is suspect in a current outbreak.
Bueno Coffee Substitute Pecan Praline Gluten-Free product contains undeclared peanut and barley (which contains gluten).
One lot of ALA 300 mg Cap-50 were labeled at Melatonin 3 mg Tab-60.
Michigan Department of Agriculture and Rural Development sampled Enoki mushrooms and found some samples to be positive for Listeria monocytogenes.
Ingredients statement declares Unsalted Cream but does not list milk. Label has allergen advisory statement "Mfg on same equipment that processes wheat, egg, peanut & tree nut. May contain…
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.
