Weekly Recap of Recalls, Withdrawals & Safety Alerts: September 5-10, 2017

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.

21 Recalls to be aware this week.

Medical Devices & Equipment:

    recalled Intra-Aortic Balloon PumpRecalled Intra-Aortic Balloon Pump
  • Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall – False Blood Detection Alarm, Ingress of Fluid into Pump. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.

Pharmaceuticals/Drugs:

  • Activase (alteplase) 100mg by Genentech: Recall – Lack of Sterility Assurance. The vials of Sterile Water for Injection may be cracked or chipped at the neck of the vial and leaking.
  • Recalled Injection Syringe
    Recalled Injection Medicine
  • Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall – Lack of Sterility Assurance.
  • Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication – FDA Recommends Separating Dosing.

Motorcycle/Scooters:

  • American Honda Recalls Motocross Off-Road Motorcycles Due to Crash and Injury Hazards (Recall Alert). The transmission gear can break, posing crash and injury hazards.

Utility/Recreational Vehicles & Automotive Accessories:

Food, Beverage & Nutritional Supplements:

    recalled muffinsRecalled Assorted Muffins
  • Product Recall by Wegmans of Assorted Muffins 4 Pack. The assorted muffin four pack may include a banana nut muffin containing walnuts, an allergen not listed on the label. People who have an allergy or sensitivity to nuts should not consume this product.
  • Simply Fresh Foods, Inc. Issues Allergy Alert on Undeclared Milk in Single Serve Cups of San Francisco Seafood Salad Made with Greek Yogurt. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
  • Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecomán Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk. The product has tested positive for Salmonella by exams done by FDA.
  • Recalled Meatball productsRecalled Meatballs
  • Northside Noodle Company Recalls Meatball Products Due To Misbranding and Undeclared Allergens.
  • Ragazzo’s Italian Style Meatball Mix recalled for soy not listed as allergen. The product contains soy, a known allergen, which is not declared on the product label.

Infant & Children Products:

    recalled baby formula
    Recalled Baby Formula
  • Garden of Life LLC Issues Recall of Baby Organic Liquid Formula. The company is concerned that if not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
  • ASHERANGEL Recalls Children’s Sleepwear Due to Violation of Federal Flammability Standard; Sold Exclusively at Amazon.com. The children’s nightgowns and pajama sets fail to meet flammability standards for children’s sleepwear, posing a risk of burn injuries to children.
  • L.L. Bean Recalls Toddler Sweater Fleece Pullovers Due to Choking Hazard. The snaps on the fleece pullovers can detach, posing a choking hazard.
  • Studio Fun International Recalls Slap Bracelets Sold with Children’s Storybooks Due to Laceration Hazard. The metal band can wear through the fabric covering of the slap bracelet, posing a laceration hazard.

Sporting Equipment:

    recalled ski helmet
    Recalled Ski Helmet
  • Smith Recalls Ski and Snowboard Helmets Due to Risk of Head Injury. The buckle on the helmet can disengage, posing a risk of head injury.

Household Products:

    recalled drawers
    Recalled Drawers
  • Ameriwood Home Recalls Chests of Drawers Due to Tip-Over and Entrapment Hazards. The recalled chests of drawers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.
  • Nantucket Distributing Recalls Patio Set Chairs Due to Fall Hazard. The fabric seat on the chairs can tear, posing a fall hazard to the user.

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