Early Alert: TactiFlex Ablation Catheter Issue from Abbott
Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues
Critical safety information, product recalls, and FDA communications for medical devices
Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues
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…
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.
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…
FDA alerts of risks with use of unauthorized infant monitoring devices, which have not been reviewed for safety and effectiveness.
FDA alerts of risks with use of unauthorized blood pressure devices, which have not been reviewed for safety and effectiveness.
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.
Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.
Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.
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…
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.
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…
DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.
One Frozen, LLC of Rochester, NY, is voluntarily recalling certain lots of Good & Gather™ Southwest-Style Burrito Bowl Blend (frozen, 12oz bags) because the product may contain shrimp (crustacean shellfish)…
Collectively (“Chetak”) is expanding its voluntary recall, initiated July 16, 2025, to include several lots of Deep-branded frozen vegetables and fruit products due to possible Salmonella contamination. The recall is…
Gina Marie Bakery of Waterbury, CT is recalling 1lb and 2 lb packages of the above-mentioned cookies because they contain undeclared allergens. People who have allergies to nuts, sesame seeds…
FOR IMMEDIATE RELEASE — Santa Cruz, CA, September 10, 2025 — Gooder Foods, Inc. is recalling 5 lots of Vegan Is Believin’ – Plant Based White Cheddar with Spirals produced…
Middlefield, OH 9/5/25 - The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling one lot of Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles in 6…
ENDICO POTATOES of MOUNT VERNON NY is recalling Endico brand PEAS AND CARROTS AND MIXED VEGETABLES, because they have the potential to be contaminated with Listeria monocytogenes, an organism which…
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…
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…
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…
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,…
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…
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…
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…
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…
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…
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…
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…