Recalls That Should Be on Your Radar—Week of August 18, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Tip Top Poultry, Inc. Issues Recall for Cooked Poultry Products Due to Listeria Risk

Tip Top Poultry, Inc., a Rockmart, Ga. establishment, is recalling approximately 135,810 pounds of fully cooked poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, diced, and mechanically separated ready to eat chicken was produced on January 21, 2019 and display “PACK DATE 01/21/19” on the labels.

The problem was discovered on August 17, 2019, when the Canadian Food Inspection Agency (CFIA) notified FSIS that a sample of product produced by Tip Top Poultry, Inc. confirmed positive for the presence of Listeria monocytogenes.

Read about this poultry recall.

AWERS Issues Recall for Grained Salmon Caviar due to Possible Clostridium Botulinum Risk

AWERS, Inc. of Bellevue, WA is voluntarily recalling Grained Salmon Caviar 95g (Sockeye Salmon Caviar).

The product may have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

Grained Salmon Caviar 95g with these codes was distributed directly in California, New York, Oregon, Washington, and in Canada. Product has been further distributed in Illinois and may have further distributed to other states.

Read about the salmon caviar recall here.

Edwards Lifesciences, LLC, Issues Recall for SAPIEN 3 Ultra Delivery System

The Edwards SAPIEN 3 Ultra delivery system is a part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. It is used to deliver and deploy the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards SAPIEN 3 transcatheter heart valve to replace a diseased aortic valve without open-heart surgery. The Edwards SAPIEN 3 Transcatheter Heart Valve System is indicated for use in patients with severe, symptomatic, aortic valve stenosis (narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery).

Edwards Lifesciences has received reports of burst balloons during implantation procedures, which have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or surgical intervention.

The use of affected product may cause serious adverse health consequences, including death.

Seventeen (17) injuries and one (1) death were reported at the time when Edwards initiated the Field Corrective Action in July 2019.

Read about the SAPIEN 3 recall.