689 recalls tagged with “fda regulated”.
Prime Food Processing LLC recalled 2,243 cases of Lava Buns with Salted Egg Yolk on November 16, 2025. The recall occurred due to undeclared milk in the product's ingredient statement. This poses a high risk to individuals with milk allergies.
Olympus Corporation of the Americas is recalling 1,082 ShockPulse Lithotripsy System SPL-S single-use probes worldwide. Investigations found the device’s generator may blink and fail to recognize the transducer, risking damage to the transducer plug or generator receptacle. Hospitals and clinics should stop using the device immediately and follow the recall instructions from Olympus.
Face Rock Creamery recalled 16 units of Vampire Slayer Garlic Cheddar cheese on November 14, 2025. The recall follows the discovery of Listeria monocytogenes in the processing area. Consumers should not consume the product and seek a refund or replacement.
Olympus Corporation of the Americas is recalling 1,684 ShockPulse-SE Lithotripsy System generators worldwide, including SPL-G models. Investigations found the generator can blink and fail to recognize the transducer, and damage to the transducer plug or generator receptacle may occur. Healthcare providers and patients should stop using the device immediately and follow recall instructions provided
Olympus Corporation of the Americas recalls 602 ShockPulse-SE Lithotripsy System reusable probes worldwide to hospitals. The recall cites a blinking generator that may fail to recognize the transducer and damage the transducer plug or generator receptacle. Hospitals and patients should stop using SPL-SR probes immediately and follow manufacturer recall instructions.
Cipla USA recalled 12,576 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025, due to a nitrosamine impurity. The impurity, N-nitroso-cinacalcet, exceeds acceptable daily intake limits. Consumers must stop using this product immediately and contact healthcare providers for guidance.
Lupin Pharmaceuticals recalled 32,736 vials of Ganirelix Acetate Injection on November 13, 2025. The recall follows the discovery of impurities in the drug. Consumers and healthcare providers should stop using the product immediately to avoid health risks.
Olympus Corporation of the Americas recalled the Inner Sheath 21 Fr., Model No. A2660T, on November 11, 2025. The recall follows reports of the ceramic tip breaking during use. Patients and healthcare providers should stop using the device immediately.
Olympus recalled 94 units of its 10 Fr. endoscopic sheath on November 11, 2025, due to complaints of the ceramic tip breaking. The defect poses a high risk for patients undergoing urological procedures. Healthcare providers and patients must stop using the device immediately.
Medline Industries recalled 163 DEXLOCK Achilles Repair Implant Kits on November 11, 2025, due to a potential hazard. Users reported drill bits fusing to the drill guide, which may prolong surgical procedures. The recall affects kits distributed nationwide in multiple states.
Pacific Seafood recalled 15,498 pounds of Raw Blackened Shrimp on November 8, 2025. The shrimp may contain undeclared sulfites, posing a health risk to sensitive individuals. The affected products were distributed in Alabama, Florida, and Massachusetts.
C.R. Bard recalled 116 units of its InLay Optima Ureteral Stent Kit on November 6, 2025. A labeling discrepancy may cause the actual size of the stent to differ from what is indicated on the label. The recall affects distribution across the U.S. and several countries worldwide.
Fresenius Kabi USA, LLC recalled 2,199,850 vials of Famotidine Injection on November 6, 2025. The recall follows reports of microbial contamination and endotoxin testing failures. Healthcare providers and consumers should stop using this product immediately.
Ventura Foods recalled 700 cases of Publix Deli Carolina-Style Mustard BBQ Sauce on November 6, 2025. Consumers reported finding foreign objects in the granulated onion ingredient. The affected product was distributed to 42 locations across multiple states and Costa Rica.
Diasol recalled 7,200 gallons of its 100125-10-DEX100 liquid concentrate on November 5, 2025. The recall affects dialysis patients in multiple states due to unassured safety and efficacy. Patients and healthcare providers must stop using this product immediately.
The Maros Group is recalling 24 bottles of Prickly Pear Jelly sold in Arizona. The recall stems from undeclared milk in the product. Consumers should not eat it and should contact The Maros Group for a refund or replacement by telephone.
GET TESTED INTERNATIONAL AB recalled 13 units of its Iodine Test on November 3, 2025. The product was distributed without necessary premarket approval. Healthcare providers and patients must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 528 syphilis test units on November 3, 2025. The recall follows the distribution of the test without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled six units of its Food Intolerance Test on November 3, 2025. The recall stems from the distribution of the product without premarket approval or clearance. Healthcare providers and patients must stop using the device immediately.
Orthofix U.S. LLC recalled 14,201 units of the Forza Ti Spacer System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Patients and healthcare providers should stop using the product immediately and follow recall instructions.