Recalls You Should Be Aware Of—Week of October 14, 2018

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

Jerky Boyz Chicken Jerky Recalls Products Due to Processing Deviation

Jerky Boyz Chicken Jerky, a Pigeon Forge, Tenn. establishment, is recalling approximately 23 pounds of ready-to-eat chicken jerky products due to a processing deviation that may have led to underprocessing of products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat chicken jerky items were produced from Sep. 6, 2018 through Sep. 26, 2018. The following products are subject to recall:

• 2.5-oz. clear plastic packages containing “Jerky BoyZ Chicken Jerky Buffalo Wing” with lot code 81101.
• 2.5-oz. clear plastic packages containing “Jerky BoyZ Chicken Jerky Kickin’ Pepper” with lot code 81101.

The products subject to recall bear establishment number “P-46388” inside the USDA mark of inspection. These items were shipped to retail locations in Tennessee.

For more information on this class I recall, check out the news release.

Valley Fine Foods Recalls Meat and Poultry Products Due to Possible Adulteration

Valley Fine Foods, a Forest City, N.C. establishment, is recalling approximately 35,516 pounds of heat-treated, not fully cooked meat and poultry products that may be adulterated due to presence of spoilage organisms that have rendered it unwholesome and unfit for human food, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The heat-treated, not fully cooked, refrigerated meat and poultry products were produced on various dates from Aug. 15, 2018 through Oct. 4, 2018.

The products subject to recall bear the establishment number “ P-22102B” or “M-22102B” on the side of the product package. These items were shipped retail locations in California, Connecticut, Maryland, Massachusetts, Michigan and North Carolina.

For a complete list of recalled product, consult the USDA’s statement.

A La Carte Foods Properties, LLC Issues Recall for Products without Benefit of Inspection

A La Carte Foods Properties, LLC, a Belle Rose, La. establishment, is recalling approximately 30,438 pounds of meat and poultry products that contain meat produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat frozen meat and poultry sausage items were produced on various dates from Jan. 3, 2017 through Oct. 2, 2018.

The products subject to recall bear establishment number “EST. 13375” or “P-13375” inside the USDA mark of inspection. These items were shipped to restaurant locations in Louisiana and Texas.

To read more about this recall, check out the official statement.

Prime Deli Corporation Recalls Salads Containing Corn Possibly Contaminated with Salmonella and Listeria Monocytogenes

Prime Deli Corporation, a Lewisville, Texas establishment, is recalling approximately 217 pounds of ready-to-eat salad with bacon products that contain a corn ingredient that may be contaminated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall bear establishment number “EST. 13553” inside the USDA mark of inspection. These items were shipped to retail locations in Texas.

The problem was discovered on October 14, 2018 when Prime Deli Corporation received notification that the corn used in the production of their Southwest Style Salad with Bacon was being recalled by their corn supplier due to Listeria monocytogenes and Salmonella concerns.

To learn more about this recall, visit the USDA’s website.

GH Foods, CA, LLC Recalls Salads Containing Corn Possibly Contaminated with Salmonella and Listeria Monocytogenes

GH Foods CA, LLC, a Sacramento, Calif. establishment, is recalling approximately 940 pounds of ready-to-eat salad with chicken products that contain a corn ingredient that may be contaminated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall bear establishment number “EST. P-39994” inside the USDA mark of inspection. These items were shipped to retail locations in California.

The problem was discovered on October 16, 2018 when GH Foods CA, LLC received notification that the corn used in the production of their ready-to-eat salads with chicken was being recalled by their corn supplier due to Listeria monocytogenes and Salmonella concerns.

For a list of products affected by this recall, check out the recall announcement.

Mary’s Harvest Fresh Foods, Inc Recalls Wraps and Salads Containing Corn Possibly Contaminated with Salmonella and Listeria Monocytogenes

Mary’s Harvest Fresh Foods, Inc., a Portland, Ore. establishment, is recalling approximately 916 pounds of ready-to-eat wrap and salad products that contain a corn ingredient that may be contaminated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat salad and wrap products were produced from Oct. 5 through Oct. 13.

The products subject to recall bear establishment number “P-39928” or “40310-M” inside the USDA mark of inspection. These items were shipped to retail locations in Idaho, Oregon, and Washington.

The problem was discovered on Oct. 15, 2018 when Mary’s Harvest Fresh Foods, Inc. received notification that the corn used in the production of their ready-to-eat wrap and salad products was being recalled by their corn supplier due to Listeria monocytogenes and Salmonella concerns.

To learn more about this recall, and other recalls linked to contaminated corn, check out the USDA’s statement.

GHSE, LLC Recalls Salads Containing Meat Product Containing Corn Possibly Contaminated with Salmonella and Listeria Monocytogenes

GHSE, LLC, a Green Cove Springs, Florida establishment, is recalling approximately 738 pounds of ready-to-eat salad with meat products that contain a corn ingredient that may be contaminated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat salads with steak were produced from Oct. 11, 2018 through Oct. 14, 2018.

The products subject to recall bear establishment number “EST. 45781” inside the USDA mark of inspection. These items were shipped to retail locations in Florida, Georgia, and South Carolina.

The problem was discovered on Oct. 15, 2018 when GHSE, LLC received notification that the corn used in the production of their ready-to-eat salad product was being recalled by their corn supplier due to Listeria monocytogenes and Salmonella concerns.

For a list of recalled products, consult the USDA’s news release.

Taylor Farms Northwest LLC Recalls Products Containing Tomatillos Possibly Contaminated with Salmonella and Listeria Monocytogenes

Taylor Farms Northwest LLC, a Kent, Wash. establishment, is recalling approximately 276 pounds of ready-to-eat (RTE) pork carnitas bowl products that contain tomatillos that may be adulterated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall bear establishment number “EST. 34834” inside the USDA mark of inspection. These items were shipped to retail locations in Oregon and Washington.

The problem was discovered on October 15, 2018 when Taylor Farms Northwest received notification that fire-roasted diced tomatillos used in the production of their pork carnitas bowls was being recalled by their tomatillos supplier due to Listeria monocytogenes and Salmonella concerns.

To learn more about this recall, visit the USDA’s recall announcement.

Endologix, Inc. Recalls Endovascular Systems Due to Risk of Type III Endoleaks

Endologix is recalling its AFX Endovascular AAA Systems due to continued reports of Type IIIa and IIIb endoleaks. When a Type III endoleak occurs, blood continues to flow into the aneurysm, increasing the likelihood of a rupture. Left undetected and without treatment, a Type III endoleak may result in serious patient injury, such as an AAA rupture or death.

The Endologix AFX Endovascular AAA System (AFX) is used to treat patients with a condition, called an abdominal aortic aneurysm (AAA), that occurs when the wall of the body's largest blood vessel (the aorta) becomes stretched and thin, causing the vessel to bulge or expand. The AFX is a thin polymer tube with a large metal stent on the inside. It is placed inside the aorta so that blood flows through the device instead of the weakened aneurysm. This helps to prevent the aneurysm from increasing in size and bursting (rupturing). The AFX is placed in a patient during a surgical procedure called endovascular aneurysm repair (EVAR).

To read more about this medical device recall, check out the recall statement.

Fat Burners Zone Issues Recall of Products Due to Undeclared Sibutramine

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

This tainted product is marketed as a dietary supplement for weight loss and is packaged in gray aluminum bottles with gray aluminum caps, 30 capsules per bottle. The affected Zero Xtreme lot, #1220062085, expires 03/2020. Zero Xtreme was distributed nationwide via interne5 through the website fatburnerszone.com.

To learn more about this recall, check out the recall notice.

Hy-Vee Inc, Issues Recall for Products Potentially Contaminated with Salmonella and Listeria monocytogenes

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee's supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these products.

All impacted products have a "Best If Used By" date of Oct. 22, 2018, or sooner.

For more information on this recall, consult the company's statement.

GHSW, LLC Issues Recall For Salad Products Potentially Contaminated with Salmonella and Listeria Monoctyogenes

GHSW, LLC, a Houston, Texas establishment, is recalling approximately 1,786 pounds of ready-to-eat salad with chicken products that contain a corn ingredient that may be contaminated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat salads with chicken were produced from Oct. 1, 2018 through Oct. 18, 2018.

The products subject to recall bear establishment number “P-44056” inside the USDA mark of inspection. These items were shipped to retail locations in Colorado, Louisiana, New Mexico, Oklahoma, Tennessee and Texas.

The problem was discovered on Oct. 15, 2018, when GHSW, LLC received notification that the corn used in the production of their ready-to-eat salad products was being recalled by their corn supplier due to Listeria monocytogenes and Salmonella concerns.

To read more about this recall, check out the USDA's statement.

LivaNova Issues Updated Information About 3T Heater-Cooler Systems

On October 18, 2018, LivaNova issued a Medical Device Correction letter to inform customers of actions to take to reduce potential cardiac surgery infection associated with the 3T Heater-Cooler Systems. The FDA is issuing this communication to help share the information provided by LivaNova.

To help reduce potential risk of infection during cardiac surgery, on October 18, 2018, LivaNova issued a Medical Device Correction letter to health care facilities to:

• Provide updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm.
• Announce the availability of a design upgrade (vacuum canister and internal sealing) that reduces the risk of potential emission of aerosols from the 3T.

To read the newly issued recommendations and for more information, consult the FDA's communication.