FDA News

12 August

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Wegmans Food Markets, Inc. Recalls Various Wegmans Camembert Soft Ripened Cheese Products Because of Possible Health Risk

Posted by Asebey Law

Rochester, N.Y. – Wegmans Food Markets, Inc. is recalling Wegmans Medium Camembert Soft Ripened Cheese, and various products containing this cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in youn Read More (external link)...

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12 August

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Quesito El Establo Retira Del Mercado Queso (Quesito Colombiano) Debido a Posible Riesgo Para La Salud

Posted by Asebey Law

Quesito El Establo, de Salem, NH, está retirando del mercado todos sus productos de Queso Español (Quesito Colombiano) fabricados en sus instalaciones, debido a la presencia de roedores, actividad de roedores y otras condiciones insalubres durante el proceso de producción y almacenamiento. Read More (external link)...

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12 August

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Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings

Posted by Asebey Law

Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or death Read More (external link)...

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12 August

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Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.

Posted by Asebey Law

Max Mobility/Permobil has voluntarily expanded its recall of the SpeedControl Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. This voluntary action applies to all SpeedControl Dials manufactured and distributed between the dates of Ap Read More (external link)...

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11 August

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Dollar General Announces Voluntary Recall of Clover Valley® Instant Coffee Due to Potential Presence of Glass

Posted by Asebey Law

Goodlettsville, Tennessee – August 11, 2025 –Dollar General Corporation is recalling three (3) lots of its eight (8) ounce Clover Valley® Instant Coffee due to the potential presence of glass. Read More (external link)...

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08 August

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Neuhaus Issues Allergy Alert on Undeclared Wheat in Belgian Chocolate Moments Smurf’s Popping Milk Chocolates with Cookies’

Posted by Asebey Law

Neuhaus Chocolates NV of Vlezenbeek, BELGIUM has initiated a voluntary recall for : Belgian Chocolate Moments Smurfs 'Popping Milk Chocolates with Cookies, because it contains undeclared wheat. People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening alle Read More (external link)...

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08 August

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DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination

Posted by Asebey Law

DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia. Read More (external link)...

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07 August

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Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps

Posted by Asebey Law

SAN DIEGO – August 7, 2025 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. Read More (external link)...

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07 August

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FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication

Posted by Asebey Law

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication Read More (external link)...

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06 August

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Early Alert: Defibrillation Lead Issue from Boston Scientific

Posted by Asebey Law

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...

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06 August

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Early Alert: Electrophysiology Catheter Issue from Medline ReNewal

Posted by Asebey Law

Recall affects certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters Read More (external link)...

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06 August

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Early Alert: WATCHMAN Access System Issue from Boston Scientific

Posted by Asebey Law

Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions Read More (external link)...

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05 August

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Friendly’s Issues Allergy Alert on Undeclared Soy/Wheat in Friendly’s Cookies & Cream Ice Cream

Posted by Asebey Law

Friendly’s Ice Cream is voluntarily recalling a limited quantity (324 cartons) of 48 fl. oz. Cookies & Cream ice cream because of undeclared soy and wheat. The recalled product was mistakenly packaged in Friendly’s Vanilla Bean ice cream cartons with a Cookies & Cream lid. People who have an allergy Read More (external link)...

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05 August

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Hans Kissle LLC Issues Allergy Alert on Undeclared Wheat (Allergen) in Hans Kissle Red Potato Bliss Salad

Posted by Asebey Law

Haverhill, MA — Hans Kissle is voluntarily recalling 66 units of Hans Kissle Red Potato Bliss Salad due to undeclared allergen (wheat). People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products. Read More (external link)...

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04 August

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Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy

Posted by Asebey Law

BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death. Read More (external link)...

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01 August

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FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication

Posted by Asebey Law

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication Read More (external link)...

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30 July

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Doehler Dry Ingredient Solutions, LLC Recalls Member’s Mark Freeze Dried Fruit Variety Pack for Listeria monocytogenes Contamination

Posted by Asebey Law

Cartersville, GA – 7/30/2025 – Doehler Dry Ingredient Solutions, LLC is recalling Member’s Mark Freeze Dried Fruit Variety Pack 15 count boxes, UPC 1 93968 50900 2 due to contamination with Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infect Read More (external link)...

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29 July

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Rhino 7S Type F3 7000 contains hidden drug ingredients

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Rhino 7S Type F3 7000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Read More (external link)...

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29 July

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Power Plus Desire contains hidden drug ingredient

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Power Plus Desire, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Read More (external link)...

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29 July

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Platinum 69000 Rhino 69 contains hidden drug ingredient

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Platinum 69000 Rhino 69, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. Read More (external link)...

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