1,264 recalls tagged with “fda regulated”.
Minongad recalled LED Gloves model ST01 after safety violations exposed battery ingestion risk. The recall covers gloves sold on Amazon with two pre-installed lithium coin batteries and four spare batteries. Consumers should stop using the gloves immediately and return them for a full refund.
Beckman Coulter recalled 685 boxes of MicroScan Neg MIC 56 panels distributed nationwide to U.S. healthcare facilities after contamination was reported in wells. Contamination could lead to unreliable antimicrobial susceptibility and organism-identification results. Health care providers should stop using the panels and follow Beckman Coulter recall instructions immediately.
Ascend Laboratories recalls 8,568 bottles of Amlodipine and Olmesartan Medoxomil tablets due to failed dissolution specifications. The recall covers products manufactured by Alkem Laboratories in India and distributed nationwide in the USA. The defect involves low dissolution results. Stop use immediately and contact Ascend Laboratories for guidance.
Bestway, Intex and Polygroup recall 5 million above-ground pools taller than 48 inches after nine deaths. The recall covers pools whose model numbers are printed on the liner outside the pool. The hazard stems from a compression strap around the pool legs that can create a foothold for a child, enabling access to the water. Stop using the pools immediately and contact the respective brands for a维修
Middlefield Original Cheese Cooperative recalled Pepper Jack cheese products sold in Kentucky, Ohio and Pennsylvania after diet contamination concerns. The recall covers 8 oz. individual units, 5 lb loaves and 40 lb loaves with lot code 251661. The hazard is possible contamination with Listeria monocytogenes. Consumers should not eat the product and should contact the company for refund or a safe-
Middlefield Original Cheese Cooperative recalled 640 pounds of cheese products due to potential Listeria monocytogenes contamination. The recall covers Monterey Jack and Farmers Cheese in multiple package sizes. Consumers should not eat the cheese and should contact the company for refunds or replacements.
A high-hazard recall is active for Quick Touch Alcohol Prep Pads. 500 cases are affected. The recall covers products from YANGZHOU YULOU PAPER PRODUCTS CO. and AUM Pharmaceuticals. Consumers should stop using immediately and consult healthcare providers for guidance.
Merck Sharp & Dohme LLC recalled 51,320 cartons of Belsomra (suvorexant) tablets after identifying a risk of delayed dissolution. This defect can delay the release of the drug, hindering sleep onset. Consumers and healthcare providers should stop using the product immediately and contact the company for guidance.
Summa Therapeutics recalled 22 units of the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter sold to healthcare facilities in New Jersey and Florida. The balloon may not meet burst specifications, raising risk during angioplasty. Healthcare providers must stop using the device immediately and follow recall instructions from Summa Therapeutics.
DJO Surgical recalled 927 ALTIVATE reverse wedge glenoid reamer heads distributed nationwide in the United States after concerns that the devices may kick or bind up during use. The issue involves model 804-06-311 and non-sterile stainless steel material. Healthcare providers and patients should stop using the device immediately and contact Encore Medical, LP for instructions.
DermaRite Industries recalled 249 bottles of DermaSarra External Analgesic on July 17, 2025 due to microbial contamination. The product, sold nationwide, carries NDC 61924-189-08 and Lot 40187.2 with an expiration date of February 2026. Consumers should stop using the product immediately and contact DermaRite for guidance.
Tractor Supply recalled three Traveller aluminum loading ramps on July 17, 2025 after determining a fall hazard. The ramps can bend or break under load. Stop using the recalled ramps and seek a full refund from Tractor Supply.
CR Bard recalled 3,670 SureStep Foley Tray System A942216 Foley Catheter Trays nationwide after discovering incorrect inserts. Mislabeling could cause infection or allergic reactions. Healthcare providers should stop using the device immediately and follow recall instructions from the manufacturer.
4,300 SureStep Foley Tray System Bardex I.C. Complete Care catheter tray units are recalled nationwide by C.R. Bard. The trays may contain incorrect inserts, creating a risk of infection or an allergic reaction. Healthcare providers and patients should stop using the device and follow Bard’s recall instructions.
DermaRite Industries’ DermaKleen antiseptic lotion soap is recalled nationwide after contamination with Burkholderia cepacia. The Class I recall covers 11,321 bag-in-box units sold nationwide. Consumers are urged to stop using the products and contact the company for guidance.
Deale International is recalling CasaClean Handheld Steamers DF-958 sold on HSN for burn risk. The steamers can leak steam or spray boiling water, creating a serious burn hazard. Consumers should stop using the product and contact Deale for a full refund.
Quest International recalls 376 Measles IgM ELISA kits nationwide in Utah, Texas and Arizona after discovering the product lacks premarket approval or clearance. The high-risk health device carries a Class II designation. Stop using the device immediately and follow manufacturer recall instructions.
Stryker Communications recalls 40 surgical light systems nationwide after reports of stress lines in the powder coating. The devices include CH00000001 and the SLX to Oculan NFC Upgrade Kit, P60034. The recall is active as of July 15, 2025. Patients and healthcare providers should stop using the devices immediately and follow manufacturer recall instructions.
BioFire Defense recalled 130 FilmArray NGDS Warrior Panel NGDS-ASY-0007 kits distributed nationwide in the United States. The recall cites an increased risk of internal control failures when testing positive blood cultures. Clinicians should stop using the device immediately and follow recall instructions provided by BioFire Defense. Notification is by letter to affected facilities.
Giant Bicycle recalls Momentum Vida E+ electric bicycles after a fork crash hazard. The recall affects bikes with specific serial numbers. Stop riding and contact Giant Bicycle for a fork replacement.