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.
40 Recalls to be aware this week.
Medical Devices & Equipment:
- Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may “lockup” (freeze) after a shock is delivered. When this occurs, the device’s monitor display goes blank and there is no response from the keypad or the device although the device’s LED lights remain on and indicates the device still has power.
- Xeljanz, Xeljanz XR (tofacitinib): Safety Communication – Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients.
- ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate.
- Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API).
- AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.
- Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP.
- Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28×3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement.
- Biotouch Recalls Topical Anesthetic Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poisoning. The package is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving gel contains lidocaine, posing a risk of poisoning to young children.
- Clinical Resolution Laboratory Recalls Topical Anesthetic Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poisoning. The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.
- Model year 2010-2014 Subarus with airbag inflator issue recalled. In the event of a crash necessitating deployment of the passenger front airbag, the inflators may explode.
- Subaru recalls model year 2018 Legacys, Outbacks, and BRZs. The review camera display may remain blank while the vehicle is backing up.
- Kia recalls model year 2012-2016 Kia Soul vehicles. High exhaust gas temperatures may damage the catalytic converter, possibly resulting in abnormal engine combustion and damage to one or more of the engine’s pistons and possible piston connecting rod failure.
- Kia recalls model year 2015-2018 Sedonas. Over time, the Occupant Detection System (ODS) wiring harness located under the front passenger seat may break from the seat being occupied.
- Subaru plans biggest-ever global recall over brake lights. Approximately 2.3 million vehicles, produced from 2008 through 2017.
- Hyundai, Kia add to 2.4 million cars recalled in U.S. over fires, engines. Another 3.7 million are subject to a ‘product improvement’ campaign.
- Harley-Davidson Motor Company is recalling 12,871 model year 2016-2019 Street 500 (XG500), Street 750 (XG750), and model year 2017-2019 Street 750A (XG750A) motorcycles. The brake calipers may corrode internally after exposure to certain driving environments such as coastal regions or road salt, resulting in increased brake drag.
- Arcimoto recalls model year 2017-2018 FUV motorcycles. The motorcycles have a number of issues.
Utility/Recreational Vehicles & Automotive Accessories:
- Model year 2019 Salem and Wildwood recreational trailers recalled. The power cord hatch is located above the water heater exhaust, possibly resulting in the cord or the hatch melting. A melted cord may result in bare wiring, increasing the risk of fire.
- Model year 2019 Serenity RVs recalled. The coach battery compartment door support metal cable may contact the positive battery terminal. If the cable contacts the positive battery terminal, a short may occur, increasing the risk of a fire.
Food, Beverage & Nutritional Supplements:
- UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist.
- B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria® Marinara Sauce Due to Possible Undeclared Cashew.
- Meijer recalls Meijer brand Ultimate Chocolate Mint Chip Cookies. The product contains soy, an allergen not declared on the label.
- Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk.
- Joy Gourmet Foods LLC Issues Allergy Alert on Undeclared Sulfites.
- Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by Salmonella.
- Concord Fresh Success Mild Salsa Seasoning Mix recalled. The product may contain milk, an allergen not declared on the label.
- Fulton Seafood recalls catfish. The products did not undergo federal inspection.
- TV Food recalls catfish. The products did not undergo import re-inspection.
- Russ Davis Wholesale – Crazy-Fresh Recalls Chicken Products due to Misbranding and Undeclared Allergens.
- Sahlen Packing Company, Inc. Recalls Ready-To-Eat Deli Meat Products Due to Possible Foreign Matter Contamination.
- McAllen Cold Storage, Ltd. Recalls Siluriformes Fish Products Produced Without Benefit Of Inspection.
- Washington Beef, LLC Recalls Ground Beef Products due to Possible Foreign Matter Contamination.
- Sofina Foods expands chicken nugget recall linked to Salmonella outbreak. The company is now recalling certain Compliments brand frozen, breaded chicken nuggets in addition to Crisp & Delicious branded products.
- Spate of dark chocolate recalls due to undeclared milk after allergic reaction. Testing of some dark chocolate in New Zealand following a consumer’s allergic reaction has found high levels of undeclared milk protein, which is a known allergen.
- Golean DETOX capsules recalled. The product contains sibutramine and phenolphthalein not declared on the label, making it an unapproved drug for which safety and efficacy have not been established.
- JumpSport Recalls Mini Trampolines Due to Injury Hazard; New Instructions and Warning Labels Provided. The folding trampoline’s frame can forcefully hit the user, posing an injury hazard.
- Shearwater recalls diving transmitters. The transmitters can fail to signal the tank pressure.
- D&D Futon Furniture Recalls Sleeper Chair Folding Foam Beds Due to Violation of Federal Mattress Flammability Standard. The mattress fails to meet the mandatory federal flammability standard for mattresses, posing a fire hazard.
- Harbor Freight Tools Recalls 12V Rechargeable Flashlights Due to Overheating and Burn Hazards. The flashlight can overheat while charging, posing a burn hazard to consumers.
- Harbor Freight Tools Recalls Propane Torches Due to Burn Hazard. The trigger on the torches that engages the flame can fail to disengage when the trigger is no longer pressed, posing a burn hazard.
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