FDA News Archives - Page 12 of 44

23 September

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Lawrence Wholesale LLC Recalls Kroger Bagged Frozen Shrimp and Kroger Frozen Shrimp Products Because of Possible Health Risk

Lawrence Wholesale LLC of Vernon, CA is recalling a limited quantity of Kroger bagged frozen shrimp and Kroger frozen shrimp products because they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with Cesium-137 (Cs-137). Read More (external link)...

23 September

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

Posted by Asebey Law

in FDA News

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 manmade radioisotope of cesium. Traces of Cs-137 are widespread and can be present in the environment at background levels, an Read More (external link)...

23 September

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AquaStar (USA) Corp Recalls AquaStar Raw Shrimp Skewers Because of Possible Health Risk

Posted by Asebey Law

in FDA News

September 23, 2025, AquaStar (USA) Corp of Seattle, WA is recalling approximately 8,000 bags (net wt. 1.25lbs) of AquaStar Raw Peeled Tail-on Shrimp Skewers (see photo), imported from Indonesia, because they may have been prepared, packed, or held under insanitary conditions whereby they may have be Read More (external link)...

23 September

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Sleep, Skin, Bodybuilding and Other Product Notifications

Posted by Asebey Law

in FDA News

Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients. Read More (external link)...

23 September

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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Posted by Asebey Law

in FDA News

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues Read More (external link)...

23 September

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Sprout Organics Expands Voluntary Recall of Sweet Potato Apple and Spinach to Include Additional Lot Codes

Posted by Asebey Law

in FDA News

Sprout Organics is expanding its September 16, 2025 recall of Sprout Organics® Sweet Potato Apple and Spinach, due to potentially elevated lead levels, to include additional lots. Read More (external link)...

20 September

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Western United Fish Company Recalls Kirkland Signature Brand Ahi Tuna Wasabi Poke Because of Possible Health Risk

Posted by Asebey Law

in FDA News

September 20, 2025, Western United Fish Company dba Annasea Foods Group of Kent, WA is recalling 3,314.7 lbs. of Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco Item Number of 17193, with the Sell By Date of 9/22/2025, because the green onions used in the product have the potential to be cont Read More (external link)...

20 September

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Aquastar (USA) Corp Recalls Kroger Frozen Raw EZ Peel, Kroger Mercado Frozen Cooked Shrimp, and Aquastar Raw Shrimp Skewers Because of Possible Health Risk

Posted by Asebey Law

in FDA News

September 19, 2025, AquaStar (USA) Corp of Seattle, WA is recalling: approximately 49,920 bags (net wt. 2lbs) of Kroger Raw Colossal EZ Peel Shrimp approximately 18,000 bags (net wt. 2lbs) of Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp approximately 17,264 bags (net wt. 1.25lbs) of AquaSt Read More (external link)...

19 September

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Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles

Posted by Asebey Law

in FDA News

CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures Read More (external link)...

18 September

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Primal Herbs Volume may be harmful due to hidden drug ingredient

Posted by Asebey Law

in FDA News

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

18 September

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Early Alert: TactiFlex Ablation Catheter Issue from Abbott

Posted by Asebey Law

in FDA News

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues Read More (external link)...

17 September

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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Posted by Asebey Law

in FDA News

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking Read More (external link)...

16 September

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Sprout Organics Voluntarily Recalls One Lot of Sweet Potato Apple and Spinach Due to Possible Health Risk

Posted by Asebey Law

in FDA News

Sprout Organics has initiated a voluntary recall of one lot of Sprout Organics® Sweet Potato Apple and Spinach because it may contain elevated levels of lead. Read More (external link)...

16 September

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Haifa Smoked Fish Recalls “Cold Smoked Salmon” and “Cold Smoked Seabass” Due to Possible Health Risk

Posted by Asebey Law

in FDA News

HAIFA SMOKED FISH OF JAMAICA NY is recalling “COLD SMOKED SALMON” 8 OZ., LOT # 219 and “COLD SMOKED SEABASS” 8 OZ., LOT # 212, because it may be contaminated with Listeria Monocytogenes. LISTERIA MONOCYTOGENES is an organism which can cause serious and sometimes fatal infections in young children, f Read More (external link)...

16 September

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Early Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas

Posted by Asebey Law

in FDA News

Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape. Read More (external link)...

16 September

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Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error

Posted by Asebey Law

in FDA News

mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly. Read More (external link)...

16 September

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Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication

Posted by Asebey Law

in FDA News

FDA alerts of risks with use of unauthorized blood pressure devices, which have not been reviewed for safety and effectiveness.   Read More (external link)...

16 September

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Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication

Posted by Asebey Law

in FDA News

FDA alerts of risks with use of unauthorized infant monitoring devices, which have not been reviewed for safety and effectiveness. Read More (external link)...

15 September

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Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery

Posted by Asebey Law

in FDA News

t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that makes the pump stop delivering insulin. Read More (external link)...

12 September

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BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets

Posted by Asebey Law

in FDA News

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc Read More (external link)...