Each week we compile a summary of Recalls, FDA warnings, market withdrawals and safety alerts that the public should be aware of for their safety and so that they can make informed decisions.

28 Recalls to be aware this week.

Medical Devices & Equipment:

• Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm.

Pharmaceuticals/Drugs:

Recalled Ranitidine Oral Solution
• Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.
• Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.
• American Health Packaging is recalling eight lots of Ranitidine Syrup. The product is contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA. The recalled product is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.
Recalled Wintergreen Essential Oil
• B&B Acquisition Recalls Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning.
• RESURRECTIONbeauty Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning.

Auto:

Recalled Mazda
• Mazda North American Operations is recalling 146 model year 2019 CX-9s equipped with Sumitomo Falken ZIEX CT50 A/S tires, size P255/50R20 104V — date code 1619. An incorrect rubber compound may have been used in the tire’s manufacturing, allowing the tread to separate and detach.
• Fiat Chrysler to recall nearly 700,000 SUVs for electrical fault risk. The recall, covering 2011 through 2013 model year Dodge Durango and Jeep Grand Cherokee SUVs, will address silicon deposits on the contact points of fuel pump relays that may interrupt electrical current.

Utility/Recreational Vehicles & Automotive Accessories:

Recalled Recreational Vehicle
• Thor Motor Coach (TMC) is recalling 378 model year 2019-2020 Chateau 22B, 22E, 23U, 24F, 25V, & 28A, Daybreak 22GO, Four Winds 22B, 22E, 24F, 26B & 28A, Freedom Elite 22HE, and 2020 Quantum GR22 & SE22 motorhomes. The seatbelt-unfastened warning light will not illuminate for approximately five seconds after the ignition is moved to the “on” or “start” position.
• Forest River is recalling 27 model year 2020 East to West Delta Terra (model 312BH) and East to West Silver Lake (model 31KBH) recreational trailers. The overhead bunk fasteners may not be properly secured to the backer board of the bunk.

Food, Beverage & Nutritional Supplements:

Recalled Whole Foods Cheesecake
• Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of Cheese Nips (11 oz. Box) Product in the U.S. Due to Potential Presence of Foreign Material.
• Allergy Alert Issued due to Undeclared Egg in Whole Foods Market Brand Raspberry Cheesecake Italian Gelato.
• You Chang Trading of Brooklyn, N.Y., is recalling an undetermined amount of raw Tilapia filets. The product was not inspected upon being imported into the U.S.
• Kettle Cuisine recalls Marketside Creamy Cauliflower Parmesan Soup. The product may contain fish and wheat, allergens not declared on the label.
• “Euroline Foods LLC” Issues Alert on Undeclared Sulfites in “Dry Fruit Mix “Quince Compote” (Tainy Vostoka)”.
• BrucePac Recalls Ready-to-Eat Chicken Sausage Products Due to Misbranding.
• Missa Bay, LLC Recalls Salad Products Due to Possible E. coli O157:H7 Contamination.
• Morris Meat Packing Recalls Pork Products Produced Without Benefit of Inspection.
• Ajinomoto Foods North America, Inc. Recalls Chicken Fried Rice Products Due To Possible Foreign Matter Contamination.
• Farm Boy is recalling Farm Boy brand cheese balls in Ontario, Canada, due to possible Listeria monocytogenes contamination.
• Med Man Distribution is recalling all lots of Up2 dietary supplement. The product, marketed as an “all-natural libido for men and women,” is tainted with sildenafil, making it an unapproved drug for which safety and efficacy have not been established.

Technology/Electronics:

• Grace Digital Recalls EcoBoulder Speakers That Can Overcharge and Burst; Impact Hazard. The speaker’s battery can become overcharged and burst, posing an impact hazard.

Sporting Equipment:

Recalled Ski Boots
• SCARPA North America Recalls Ski Boots Due to Fall Hazard. The ski boot shell can crack, posing a fall hazard and risk of injury to the consumer.

Household Products:

• Sears Holdings Management Corporation of Hoffman Estates, Ill., is recalling about 700 Kenmore Elite microwave ovens. Incorrect wiring causes the microwave’s exterior to reach temperatures exceeding 183 degrees Fahrenheit, posing a burn hazard.
• United National Closeout Stores Recalls Isometric Exercise Devices Due to Projectile Hazard; Devices Sold at Burlington Stores After 2014 Recall. The handle grips on each end can break during use and cause parts to be forcefully ejected from the shaft, posing a risk of injury from impact to the user or bystander.
• Flying Tiger Copenhagen Recalls Crocodile Candleholders Due to Fire Hazard. The candleholders are flammable and can catch on fire, posing a fire hazard when the candle burns down.

Miscellaneous:

• Briggs & Stratton Recalls Snapper Rear Engine Riding Mowers Due to Injury Hazard. A faulty blade engagement lever can keep the lawnmower blade engaged after the release of the foot activated disengagement pedal, posing an injury hazard.
• Deck Source Recalls Cutek Proclean Due to Violation of FHSA Labeling Requirements; Risk of Poisoning. The product contains the hazardous substance oxalic acid. The label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word “poison” and printing the mandatory hazard statement for poisonous chemicals on the back of the label instead of the front, posing a risk of poisoning if swallowed by children.

Sources:

fda.gov, cspc.gov, usda.gov, reuters.com, safekids.org, goodhousekeeping.com, consumeraffairs.com, foodsafetynews.com, usatoday.com, autoblog.com, powersportsbusiness.com, roadandtrack.com, uscgboating.org, wemakeitsafer.com, guns.com

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