Recalls That Should Be On Your Radar—February 10, 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:

Food Safety Recalls:

World Waters Issues Recall of Select WTRMLN WTR 12 Packs due to Potential Presence of Plastic

World Waters, LLC is initiating a voluntary recall of certain lots of Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products. The product subject to this voluntary recall is found below.

The company urges consumers to check the package prior to consumption. While no adverse events associated with the products have been reported to date, the presence of the plastic could potentially be a choking hazard. Accordingly, out of an abundance of caution and to ensure consumer safety, the company is recalling the products to the retail and consumer level.

For more information, check out the recall announcement.

McDaniel Life-Line LLC Issues Recall for Indian Herb Marketed Without an Approved NDA/ANDA

Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury.

Use of the product could result in temporary or permanent damage or loss of body function or structure. To date, McDaniel Life-Line LLC has received a report of one adverse injury.

For more information, check out the news release.

Panola County Processing, LLC Recalls Sausage Products due to Possible Processing Deviation

Panola County Processing, LLC, a Carthage, Texas establishment, is voluntarily recalling approximately 59 pounds of smoked sausage 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 pork smoked sausage links and venison and pork sausage links items were produced on Jan. 29, 2019.

The products subject to recall bear establishment number “EST. 48219” inside the USDA mark of inspection. These items were distributed to a retail location in Texas.

The problem was discovered by FSIS personnel while performing verification activities at the establishment on Feb.8, 2019.

To read more about this recall, consult the USDA’s statement.

Medical Device and Product Recalls:

Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators due to Possible Circuit Error

Medtronic is recalling its dual chamber IPGs due to the possibility of a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death.

Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other electronic parts. The pulse generator must be used with insulated electrode wires called leads. These devices are designed to be used in addition to routine clinical monitoring by a health care professional.

For additional information read the safety recall statement.