FDA News

29 August

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Updated Release: Southwind Foods, LLC Recalls Frozen Shrimp Because of Possible Health Risk

Posted by Asebey Law

Southwind Foods, LLC of Carson, California is voluntarily recalling a limited quantity of Frozen Shrimp, due to possible radionuclide (Cesium-137) contamination. Cs-137 is a man-made radioisotope of cesium. Traces of Cs-137 are widespread and can be present in the environment at background levels, a Read More (external link)...

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29 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 120 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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29 August

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Ice Cream Factory Issues Allergy Alert on Undeclared Almond in Vanilla G.Nutt Ice Cream

Posted by Asebey Law

Ice Cream Factory of Mount Vernon, NY is recalling 40 Pints, 8 Quarts and 3 Half Gallons of Vanilla G.Nutt ice cream, because it may contain undeclared almond. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume Read More (external link)...

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29 August

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Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings

Posted by Asebey Law

Costa Mesa, California August 28, 2025 - Green Lumber Holding, LLC (“Green Lumber”) is alerting consumers that counterfeit products misrepresented as genuine Green Lumber have been identified and may pose health risks. Read More (external link)...

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29 August

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Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port

Posted by Asebey Law

A blocked manometer port on the Ambu SPUR II resuscitator may delay ventilation or cause barotrauma Read More (external link)...

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29 August

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Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation

Posted by Asebey Law

Hamilton Medical is recalling certain coaxial breathing sets due to a defect that may cause cracks in the inner tube, risking patient rebreathing exhaled gases. Read More (external link)...

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29 August

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Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into Place

Posted by Asebey Law

Abbott Medical is removing power cords associated with the HeartMate Mobile Power Unit due to a potential risk of the cord not locking into place. Read More (external link)...

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28 August

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Aquastar (USA) Corp Recalls Cocktail Shrimp 6oz Because of Possible Health Risk

Posted by Asebey Law

August 28, 2025, AquaStar (USA) Corp of Seattle, WA is recalling approximately 26,460 packages of Cocktail Shrimp 6oz (see photo), imported from Indonesia, because they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with cesium-137 (Cs-1 Read More (external link)...

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28 August

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Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive

Posted by Asebey Law

ICU Medical is correcting the Plum Duo infusion system due to pump software issues that may cause the device to become unresponsive. Read More (external link)...

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28 August

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Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns

Posted by Asebey Law

Extended Tip Applicator recall due to potential non-sterile product and high endotoxin levels. May cause inflammation or infection if used. Read More (external link)...

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28 August

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Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board

Posted by Asebey Law

Hamilton is repairing certain HAMILTON-C6 ventilators to replace a defective circuit board that can interrupt ventilation, risking serious injury or death. Read More (external link)...

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27 August

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DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination

Posted by Asebey Law

DermaRite Industries, LLC is expanding the voluntary recall initiated on July 16, due to potential microbial contamination identified as Burkholderia cepacia complex. Out of an abundance of caution the voluntary recall has expanded to include additional products and lots, which can be found in the t Read More (external link)...

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27 August

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Country Eggs, LLC Recalls Large Brown Cage Free “Sunshine Yolks” Because of Possible Health Risk

Posted by Asebey Law

Country Eggs, LLC of Lucerne Valley, CA is recalling our LARGE BROWN CAGE FREE SUNSHINE YOLKS because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immun Read More (external link)...

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27 August

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Aquastar (USA) Corp Recalls Kroger Mercado Frozen Cooked Shrimp Because of Possible Health Risk

Posted by Asebey Law

August 27, 2025, AquaStar (USA) Corp of Seattle, WA is recalling approximately 18,000 bags (net wt. 2lbs) of Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp because they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with cesium-137 Read More (external link)...

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27 August

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Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling

Posted by Asebey Law

08/27/2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam Read More (external link)...

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26 August

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Company Voluntarily Recalls Honey Balsamic Salad Kit Due to Potential Undeclared Sesame and Soy

Posted by Asebey Law

Salinas, Calif., August 26, 2025 – In response to a recall initiated by Latitude 36 Foods, LLC., Taylor Fresh Foods is voluntarily recalling the Taylor Farms Honey Balsamic Salad Kit 6/8.3oz. because it may contain undeclared sesame and soy allergens. People who have an allergy or severe sensitivity Read More (external link)...

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25 August

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Viva Raw Issues Voluntary Recall of Two Lots of Dog an Cat Foods Due to Salmonella and Listeria Monocytogenes Contamination

Posted by Asebey Law

August 25, 2025 – Viva Raw LLC, Charlotte, NC is voluntarily recalling two lots of dog and cat foods due to contamination with Salmonella and Listeria monocytogenes. The recall is for Lot 21495 (Viva Ground Beef for Dogs; Viva Beef & Turkey for Puppies) and Lot 21975 (Viva Ground Chicken for Dogs; Read More (external link)...

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25 August

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Viva Raw Issues Voluntary Recall of Two Lots of Dog and Cat Foods Due to Salmonella and Listeria Monocytogenes Contamination

Posted by Asebey Law

August 25, 2025 – Viva Raw LLC, Charlotte, NC is voluntarily recalling two lots of dog and cat foods due to contamination with Salmonella and Listeria monocytogenes. The recall is for Lot 21495 (Viva Ground Beef for Dogs; Viva Beef & Turkey for Puppies) and Lot 21975 (Viva Ground Chicken for Dogs; Read More (external link)...

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25 August

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FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

Posted by Asebey Law

On August 22, 2025,the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of Read More (external link)...

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25 August

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Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices – Letter to Health Care Providers

Posted by Asebey Law

The FDA is reminding the public about the safe use of hyperbaric oxygen therapy devices and is providing recommendations to help reduce potential risks. Read More (external link)...

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