Picket Fence Creamery L.L.C. Recalls

Undeclared soy lecithin.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

White Chocolate Raspberry Ice Cream (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Jalapeno-Ranch White Cheddar Cheese Curds (Picket Fence) – undeclared soy (2021)

Undeclared soy lecithin.

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Class IIModerate

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Taco White Cheddar Cheese Curds (Picket Fence) – undeclared wheat (2021)

Undeclared Gluten

Undeclared wheat, no gluten free labeling.

FDASep 15, 2021IN, IA• Picket Fence Creamery L.L.C.

Medtronic Bio-Medicus Insertion Kits (Medtronic) – Label Mix-up (2021)

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

FDASep 13, 2021Nationwide• Medtronic Perfusion Systems

Anise Almond Biscotti (Enrico Biscotti) – Undeclared Soy (2021)

Undeclared soy

FDASep 13, 2021IN, NY, OH• The Enrico Biscotti Company

Cranberry Pistachio Biscotti (Enrico Biscotti) – Undeclared Soy (2021)

Undeclared soy

FDASep 13, 2021IN, NY, OH• The Enrico Biscotti Company

Tuscany GMC Sierra 1500 (Tuscany) – Suspension Component Risk (2021)

Fox Factory, Inc. (Fox Factory) is recalling certain 2019-2021 GMC Sierra 1500 and Chevrolet Silverado 1500 vehicles that are equipped with Tuscany Kits, model number 501T-02-00064. Excessive wear to the front-upper control arm ball joints could result in ball joint failure and wheel separation.

NHTSASep 10, 2021Nationwide• TUSCANY MOTOR CO

TomoHelical Treatment Plans (RaySearch) – Jaw Position Error (2021)

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

FDASep 9, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

C315-HIS Delivery Catheter (Medtronic) – Lead Passage Issue (2021)

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

FDASep 9, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Coachmen Sportscoach (Coachmen) – Cooktop Safety Problem (2021)

Fire/Burn Risk

Forest River, Inc. (Forest River) is recalling certain 2021-2022 Coachmen Sportscoach motorhomes. The outdoor cooktop can be stowed with the propane hose connected.

NHTSASep 9, 2021Nationwide• COACHMEN

Ruzurgi Tablets (Jacobus) – Microbial Contamination (2021)

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

Class IHigh

FDASep 9, 2021Nationwide• Jacobus Pharmaceutical Company Inc.

BD Nexiva Catheter (Becton Dickinson) – Packaging Sterility Issue (2021)

There is a breach in the product packaging that renders the product non-sterile.

FDASep 8, 2021Nationwide• Becton Dickinson Infusion Therapy Systems Inc.

Banquet Cut Salmon (Seabear) – Botulinum Risk (2021)

Potential for growth of C. botulinum

FDASep 8, 2021AZ, CA, GA +1 more• Seabear Company

Raspberry Fudge Cordial (Velvet) – Undeclared Allergen (2021)

Undeclared Allergen

Class IHigh

FDASep 6, 2021IN, KY, MI +3 more• Velvet Ice Cream Company

Coachmen Nova (Coachmen) – Battery Installation Problem (2021)

Forest River, Inc. (Forest River) is recalling certain 2021-2022 Coachmen Nova motorhomes. The Absorbed Glass Mat (AGM) battery was incorrectly installed inside the vehicle, which can allow hydrogen gas to enter the vehicle.

NHTSASep 3, 2021Nationwide• COACHMEN

Cummins Electric Drivetrain (Cummins) – Electrical System Risk (2021)

Cummins, Inc. (Cummins) is recalling certain Electric Drivetrain Systems, model number BES CM2450 EV101B, and part number D1U0001BX03. When a system shutdown occurs, the high voltage shutdown override switch may not function, with no warning to the driver.

NHTSASep 3, 2021Nationwide• CUMMINS

ELI 280 Electrocardiograph (Welch Allyn) – Workflow Malfunction (2021)

The devices malfunction under specific operator workflows.

FDASep 3, 2021Nationwide• Welch Allyn Inc Mortara

cobas EGFR Mutation Test (Roche) – False Mutation Detection (2021)

False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment