The HMC Group Marketing Inc Recalls

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

HMC Farms White Nectarines 2lb Bag (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

HMC Farms Peaches 4lb Box (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

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Class IHigh

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

HMC Farms Nectarines 2lb Bag (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

HMC Farms White Nectarines 4lb Box (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

HMC Farms Nectarines 4lb Bag (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

Bix Produce Mixed Fruit with Grapes (FreshPoint) – Salmonella Risk (2023)

Potential Salmonella contamination.

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

HMC Farms Plums 2lb Bag (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

HMC Farms Peaches Signature 2lb Bag (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

Mixed Fruit Cup (FreshPoint) – Salmonella Risk (2023)

Potential Salmonella contamination.

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Bix Produce Mixed Fruit (FreshPoint) – Salmonella Risk (2023)

Potential Salmonella contamination.

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

HMC Farms White Peaches 2lb Bag (HMC Group) – Listeria Risk (2023)

Potential contamination with Listeria monocytogenes

FDANov 17, 2023AL, AK, AZ +24 more• The HMC Group Marketing Inc

Bix Produce Fruit Mix (FreshPoint) – Salmonella Contamination (2023)

Potential Salmonella contamination.

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Bix Produce Cut Cantaloupe (FreshPoint) – Salmonella Risk (2023)

Potential Salmonella contamination.

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Cantaloupe Fruit Cup (FreshPoint) - Salmonella Risk (2023)

Potential Salmonella contamination.

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

Chunk Melon with Grape (FreshPoint) - Salmonella Risk (2023)

Potential Salmonella contamination.

FDANov 17, 2023IA, MN, ND +1 more• FreshPoint Bix Produce Company, LLC

PosiFlush Saline Syringe (BD) – Incorrect Stopper (2023)

An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.

Moderate

FDANov 16, 2023Nationwide• Becton Dickinson & Company

X-ray System (Canon) – Detector Image Abnormality (2023)

VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.

Moderate

FDANov 15, 2023CA, LA• Canon Medical System, USA, INC.

Guardian 4 Glucose Sensor (Medtronic) – GOX Layer Thickness (2023)

Laceration Risk

Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.

Moderate

FDANov 15, 2023Nationwide• Medtronic MiniMed, Inc.

Catamount Tracks Ice Cream (Wilcox) – Listeria contamination (2023)

Products may be contaminated with Listeria monocytogenes.