Recalls That Should Be on Your Radar—Week of June 2, 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:

Hamilton Medical AG Issues Recall of Hamilton-G5 Ventilators Due to Error Message

Hamilton Medical AG is updating all HAMILTON-G5 Ventilators (PN 159001 that contains the software versions ≤ 2.60) with a newly developed software version 2.80, to reduce the probability of the user message “Panel connection lost” and ventilator entering an ambient state. The user error message is due to a blocked or terminated communication between the ventilation unit processor and the interaction panel processor.

On February 11, 2019 and March 20, 2019, Hamilton Medical AG issued safety communications to the users for the Hamilton G5 Ventilators (PN 159001), due to the "Panel connection lost" error.

While there have been complaints due to the user message error: “Panel connection lost”, no patient injury or harm were reported. The user message error “Panel connection lost” can occur sporadically, and release both a visual and an acoustical high-priority alarm to alert medical staff.

Read about this recall here.

NOVIS PR LLC Issues Recall of PECGEN DMX Due to Labeling Error

Novis PR LLC is voluntarily recalling 5 lots of PECGEN DMX, 16 oz, a liquid cough syrup to the consumer level. The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label (example below) incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician.

The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.

Read more about this recall here.

Table 87 Frozen, LLC Issues Recall for Pork Pizza Products Without Benefit of Inspection

Table 87 Frozen, LLC., a Brooklyn, N.Y. firm, is recalling approximately 649 pounds of frozen pizza products that contain pork that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen prosciutto pizza products were produced from April 1, 2019 through June 4, 2019.

The products subject to recall bear establishment number “EST. 51192” inside the USDA mark of inspection. These items were shipped to retail and wholesale locations, as well as through online sales, nationwide.

The problem was discovered on June 4, 2019, when the New York State Department of Agriculture and Markets contacted FSIS inquiring as to whether the plant was operating under a USDA Grant of Inspection.

Read more about this recall here.

Purdue Foods LLC Issues Recall for Simply Smart Organic Poultry Products Due to Possible Foreign Matter Contamination

Perdue Foods LLC., a Bridgewater, Va. establishment, is recalling approximately 31,703 pounds of ready-to-eat chicken products that may be contaminated with extraneous materials, specifically pieces of bone material, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The fully cooked chicken products were produced on March 21, 2019. The products subject to recall bear establishment number “EST. P-369” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

Read more about this recall here.

Johnsonville, LLC, Issues Recall for Ready-to-Eat Jalapeño Sausage Due to Possible Foreign Matter Contamination

Johnsonville, LLC., a Sheboygan Falls, Wis. establishment, is recalling approximately 95,393 pounds of its ready-to-eat jalapeño cheddar smoked sausage products that may be contaminated with extraneous material, specifically hard green plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The jalapeño cheddar smoked sausage items were produced and packaged on March 12 and 13, 2019.

The products subject to recall bear establishment number “EST. 34224” inside the USDA mark of inspection. These items were shipped nationwide and internationally.The problem was discovered when the company notified FSIS that they received a consumer complaint regarding green hard plastic in the product.

Read more about this recall here.

Los Hernandez Tamales, LLC Issues Recalls for Pork and Chicken Products Produced Without Benefit of Inspection

Los Hernandez, LLC., a Moxee, Wash. establishment, is recalling approximately 9,090 pounds of chicken and pork tamales that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

These items were shipped to a Los Hernandez Tamales Restaurant in Union Gap, Washington, owned by the recalling establishment. The individual tamales may have been packaged and sold to consumers from December 2018 through May 1, 2019. There are no specific identifying labels for consumers who may have carried out the tamales from the restaurant.

The problem was discovered during routine FSIS verification activities.

Read more about this recall here.