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FDA Warning & Recall Information

TruLaw FDA Warning Image

Kansas City, Missouri-based Russell Stover Chocolates has issued an allergy alert and a voluntary recall of its Sugar Free Peanut Butter Cups under two Best-Before dates due to possible undeclared pecans, reports the FDA. The move was made on February 28, 2023, after a number […]

Mar 3, 2023 By TruLaw

FDA Warns – Russell Stover Chocolates recalls certain Sugar Free Peanut Butter Cups due to undeclared pecan

TruLaw FDA Warning Image

The FDA is informing healthcare providers of an issue regarding potential insufficient packaging sterility in the HLS Set Advanced part of the Getinge/Maquet Cardiohelp system.  Used to oxygenate and remove carbon dioxide from blood as it pumps through the extracorporeal bypass circuit for circulatory and/or […]

Mar 2, 2023 By TruLaw

TruLaw Alerts – Getinge/Maquet recalls HLS Set Advanced of Cardiohelp System due to possible insufficient packaging sterility

TruLaw FDA Warning Image

On February 27, 2023, the FDA alerted healthcare providers that it has reason to believe Abbott Trifecta valves may be subject to early structural valve deterioration (SVD). The referenced devices include both the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which […]

Mar 1, 2023 By TruLaw

FDA warns of possible early structural valve deterioration in Abbott Trifecta Valves

TruLaw FDA Warning Image

On February 27, 2023, the FDA released an update to a safety communication regarding the use of Apyx Medical’s Renuvion/J-Plasma Device system in certain aesthetic skin procedures. As of this writing, Renuvion APR Handpiece by Apyx Medical has been approved for “the delivery of radiofrequency […]

Mar 1, 2023 By TruLaw

FDA Warns – Renuvion/J-Plasma Device by Apyx Medical cleared for only limited types of aesthetic procedures

TruLaw FDA Warning Image

The FDA is calling to attention a voluntary recall of one batch of Delsam Pharma Artificial Eye Ointment by Global Pharma Healthcare because of potential microbial contamination. Though the company has not received any reports of adverse events, it recalled Batch Number H29 of the […]

Feb 27, 2023 By TruLaw

FDA Alerts – 1 batch of Delsam Pharma Artificial Eye Ointment voluntarily recalled due to risk of infection, blindness

TruLaw FDA Warning Image

On February 22, 2023, Bindle Bottle LLC announced a voluntary recall of its 32-ounce, 24-ounce, 20-ounce, and 13-ounce insulated food and drink bottles after it was discovered that the product’s bottom storage compartment may contain a 0.4-inch diameter of exposed lead. Officials said any unpackaged […]

Feb 24, 2023 By TruLaw

FDA Alerts – Bindle Bottles voluntarily recalled due to possible lead adulteration

TruLaw FDA Warning Image

Oxford, Pennsylvania-based Sunny Dell Foods, LLC has recalled one lot of its “Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms” because the product may have traces of pine nuts that are not disclosed in product labeling, according to the FDA. Insufficient labeling presents a […]

Feb 24, 2023 By TruLaw

FDA Warns – Sunny Dell Foods, LLC recalls 1 lot of Rao’s Homemade Roasted Red Peppers with Portobello Mushroom due to undeclared tree nuts

TruLaw FDA Warning Image

According to the FDA, nanoMaterials Discovery Corporation has issued a nationwide, consumer-level voluntary recall of all batches of its “Snowy Range Blue”-branded Alcohol Antiseptic 80% Alcohol Solution. Announced on February 14, 2023, the Seattle, Washington-based company initiated the move after it found reason to believe […]

Feb 22, 2023 By TruLaw

FDA Warns – Voluntary recall of all batches of Alcohol Antiseptic 80% Alcohol Solution by nanoMaterials Discovery Corporation

TruLaw FDA Warning Image

As a precautionary measure, Reckitt recalled two select batches of its ProSobee 12.9 oz. Simply Plant-Based Infant Formula on February 20, 2023, after learning of potential cross-contamination with the microbe Cronobacter sakazakii. The action was initiated even as extensive testing confirmed the product was negative […]

Feb 21, 2023 By TruLaw

FDA Alerts – 2 batches of Prosobee 12.9 oz Simply Plant-Based Infant Formula recalled by Reckitt

TruLaw FDA Warning Image

The FDA is alerting consumers to a number of updates regarding a Class I recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests by Magellan Diagnostics. Initiated by Magellan Diagnostics on May 28, 2021 due to a high risk of falsely low […]

Feb 20, 2023 By TruLaw

FDA Alerts – Class I recall of LeadCare II, LeadCare Plus, LeadCare Ultra Blood Lead Tests by Magellan Diagnostics

TruLaw FDA Warning Image

Silvestri Sweets Inc. has issued a voluntary allergy alert and recall of its Favorite Day-branded Valentine’s Milk Chocolate Covered Caramels with Nonpareils due to possible traces of undisclosed tree nuts, according to the FDA. The inadequate labeling poses a risk to people with allergies or […]

Feb 17, 2023 By TruLaw

FDA Warns – Silvestri Sweets recalls Favorite Day Valentine’s Milk Chocolate Covered Caramels with Nonpareils due to undeclared pecan

TruLaw FDA Warning Image

According to the FDA, a recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems has been identified as Class I due to a potential product defect and missing part that could result in serious injury or death. Indicated for use by healthcare professionals to assess […]

Feb 16, 2023 By TruLaw

FDA Alerts – Class I recall of Nuclear Medicine 600/800 Series systems by GE HealthCare due to missing parts

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