May 5, 2024 – May 11, 2024 – 7 Recalls (7 FDA, 0 USDA)

Industries: Medical Devices, Confections, Formula, Supplements, Nuts, and Dairy

Current FDA & USDA Recall Trends

FDA

Recall / Contributing Factor(s)

  • 5/10/24 – Medical Devices – Mega Soft Pediatric Patient Return Electrode – Reports of patient burn injuries.
    • “Cincinnati, OH – May 10, 2024 – MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries..” 1
  • 5/10/24 – Food & Beverage – Yogurt covered pretzels – Potential to be contaminated with Salmonella.
    • The recall was as the result of a routine sampling program by the source supplier of the yogurt coating, which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.” 2
  • 5/10/24 – Food & Beverage – Goat Milk Formula Recipe Kit – Product does not provide sufficient nutrition when used as an infant formula.
    • “FDA notified Mt. Capra of an adverse event report of anemia in one infant. FDA determined that while the caregivers were using the Goat Milk Formula Recipe Kit and recipe, the caregivers substituted some ingredients with a different brand of multivitamin, which created a product deficient in vitamin B12 as well as folate and ultimately resulted in the development of anemia.” 3
  • 5/9/24 – Food & Beverage – Amyloid Complete dietary supplement capsules – Undeclared shellfish (shrimp, crab) allergens.
    • “The issue was identified through a customer complaint which found bottles of Amyloid Complete may contain Perna Plus Tabs with DMG, resulting in undeclared shellfish. No illnesses have been reported to date.” 4
  • 5/8/24 – Food & Beverage – 1 lb and 8 oz nuts, snack mixes, seeds, snack sticks – Undeclared peanut, tree nuts, soy, milk, sesame, and wheat allergens.
    • “The problem came about with a routine check from the Texas Department of state and Health Services. When they inspected the packaging machine they decided that cross contamination was possible as our labels do states tree nut but each tree nut was not named individually. Our packaging machine is cleaned properly however our written documentation did not clearly state that.” 5
  • 5/6/24 – Food & Beverage – Plain Whipped Cream Cheese, Plain Cream Cheese, and Cookies & Cream Mix. – Potential to be contaminated with Salmonella.
    • “WEST DES MOINES, Iowa (May 6, 2024) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two varieties of its Hy-Vee Cream Cheese Spread out of an abundance of caution due to the potential for contamination with Salmonella. Additionally, Hy-Vee is voluntarily recalling its bulk-packaged Cookies & Cream Mix out of an abundance of caution due to the potential for contamination with Salmonella.”6
  • 5/6/24 – Food & Beverage – Various Confectionary Products – Potential to be contaminated with Salmonella.
    • “Palmer Candy was notified by its liquid coating supplier that there was a potential for contamination with salmonella from an ingredient that was potentially contaminated from one of their suppliers.” 7

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient

2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/western-mixers-produce-nuts-inc-recalls-yogurt-covered-pretzels-because-possible-health-risk

3 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/healthwest-minerals-inc-dba-mt-capra-products-recalls-goat-milk-formula-recipe-kit-and-warns

4 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/davinci-laboratories-issues-allergy-alert-undeclared-shellfish-allergen-amyloid-complete-product-lot

5 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/texas-pecan-issues-allergy-alert-undeclared-tree-nuts-not-named-individually-soy-dairymilk-sesame

6 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall_supplier-recalls-impact-two-hy-vee-products-third-party-manufacturers-alert-retailer

7 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/palmer-candy-company-recalls-white-confectionary-products-because-possible-health-risk

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