29
September
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What is a Medical Device Recall?
in FDA News
What is a Medical Device Recall? Read More (external link)...
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FDA News
29
September
What is an Early Alert?
in FDA News
Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication Read More (external link)...
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29
September
Recall and Alert Resources
in FDA News
.This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices Read More (external link)...
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29
September
Update on Alert: Infusion Set Performance Issue from BD
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. Read More (external link)...
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29
September
Update on Alert: Infusion Set Performance Issue from BD
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. Read More (external link)...
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26
September
SLR Food Distribution, Inc. Recalls Wise Wife Brand Ground Cinnamon Because of Possible Health Risk
in FDA News
SLR Food Distribution of Hicksville, NY is recalling Wise Wife brand Cinnamon, because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only Read More (external link)...
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26
September
Georgia Nut Company (GNC), Third-Party Manufacturer for Tru Fru, LLC Issues Voluntary Recall of Specific Varieties of Tru Fru Freeze Dried Products Due to Potential Presence of Metal in Product
in FDA News
Today, Tru Fru, LLC announced that its third-party manufacturer, Georgia Nut Company (GNC) issued a voluntary recall of specific varieties of Tru Fru Freeze Dried products due to the potential presence of metal in the product. Hard or sharp foreign objects in food may cause traumatic injury includi Read More (external link)...
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26
September
Gansu Zhaofeng Agricultural Development Co., Ltd. Is Voluntarily Recalling Its Dried Bean Curd Due to Undeclared Wheat
in FDA News
Gansu Zhaofeng Agricultural Development Co., Ltd.in Hui County Industrial Concentration Zone, Longnan City, Gansu Province has voluntarily recalled 500g/bag G&L FOOD Dried Bean Curd for failing to declare the allergen wheat. People who have an allergy or severe sensitivity to wheat run the risk of s Read More (external link)...
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24
September
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
in FDA News
Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used. Read More (external link)...
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24
September
Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
in FDA News
3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label. Read More (external link)...
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23
September
Lawrence Wholesale LLC Recalls Kroger Bagged Frozen Shrimp and Kroger Frozen Shrimp Products Because of Possible Health Risk
in FDA News
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)...
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23
September
Updated Release: Southwind Foods, LLC Recalls Frozen Shrimp Because of Possible Health Risk
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)...
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23
September
AquaStar (USA) Corp Recalls AquaStar Raw Shrimp Skewers Because of Possible Health Risk
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)...
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23
September
Sleep, Skin, Bodybuilding and Other Product Notifications
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)...
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23
September
Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
in FDA News
FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues Read More (external link)...
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23
September
Sprout Organics Expands Voluntary Recall of Sweet Potato Apple and Spinach to Include Additional Lot Codes
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)...
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20
September
Western United Fish Company Recalls Kirkland Signature Brand Ahi Tuna Wasabi Poke Because of Possible Health Risk
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)...
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20
September
Aquastar (USA) Corp Recalls Kroger Frozen Raw EZ Peel, Kroger Mercado Frozen Cooked Shrimp, and Aquastar Raw Shrimp Skewers Because of Possible Health Risk
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)...
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19
September
Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles
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)...
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18
September
Primal Herbs Volume may be harmful due to hidden drug ingredient
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)...
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