Florida recalls

Sold nationwide. Game Changer Products LLC is voluntarily recalling all lots of 10 Day Forecast capsules sold as a male sexual enhancement product. FDA analysis found the product contains undeclared sildenafil and acetaminophen. The notice says sildenafil may interact with nitrate drugs such as nitroglycerin and cause a dangerous drop in blood pressure, and acetaminophen may cause serious liver damage in people already taking acetaminophen products.

Serious·FDA·Nov 12, 2026·Game Changer Products

Sold nationwide. Eros Apothecary of Indio, California is recalling Candy Power For Man Organic Honey after FDA laboratory testing found undeclared tadalafil, the active ingredient in the prescription drug Cialis. The notice says the tadalafil may interact with nitrate medications, such as nitroglycerin, and cause a dangerous drop in blood pressure. The product was sold on eBay between April 27, 2026, and July 20, 2026.

Moderate·FDA·Nov 12, 2026·Eros Apothecary

Sold nationwide. IMRIS is recalling five operating suite models that include ORT400 tables, because the operating suites contain Baxter TruSystem surgical tables that Baxter is recalling. The five products are the iMRX System, Neuro III-SV, iMRI 3T S, InVision 3T Operating Suite and InVision 1.5T Operating Suite, with 22 units affected in total. The notice reports no injuries and does not specify a remedy; it was distributed in the US and China.

Moderate·FDA·Nov 12, 2026·IMRIS5 products

Sold nationwide. VB Spine LLC is recalling its blunt nitinol K-wire, catalog number 48280232, used in spinal surgery. The wire may fracture during use, which could delay the procedure and may leave a piece of the broken wire in the patient's bone. No injuries have been reported.

Moderate·FDA·Nov 12, 2026·VB Spine

Sold nationwide. Securitas Healthcare LLC is recalling Arial Call Stations because their batteries may fully deplete without a low battery alert. The recall covers models CSK200, CSK200MR, CSK200-900, CSK200-900MR, CSK200-1069 and CSK200-1069MR with software version V1.6.4 (FW). The notice reports no injuries.

Moderate·FDA·Nov 12, 2026·Securitas Healthcare

Sold nationwide. A software defect in the Tandem Mobi Android app can reduce the immediate portion of an extended bolus to 0 units when the entered glucose value equals the user's active target glucose. The total insulin delivered may be less than intended, and the app does not give a separate alert when the immediate portion is omitted. This could lead to unrecognized under-delivery of insulin and high blood sugar.

Moderate·FDA·Nov 12, 2026·Tandem Diabetes Care

Sold nationwide. Beyond Air is recalling 181 cylinders of 45 ppm nitric oxide calibration gas used with the LungFit PH device. Some cylinders may have been contaminated with oxygen from the air. The notice reports no injuries.

Moderate·FDA·Nov 12, 2026·Beyond Air

Sold nationwide. GE recalled two MRI scanners: the 1.5T SIGNA Artist (System ID 585214MRAO) and the 3.0T SIGNA Architect (System ID 905684MR3T), with one unit of each affected. Certain protocols can produce incorrect, elevated liver stiffness measurements, which could contribute to inappropriate clinical management decisions. No injuries have been reported.

Moderate·FDA·Nov 12, 2026·GE2 products

Sold nationwide. Medartis AG recalled one lot of its APTUS TriLock scaphoid bone plate, model A-4350.81, because the plate may be incorrectly bent. The notice reports no injuries. The 65 affected units were distributed nationwide, including in Indiana, Arizona, California, and New York.

Moderate·FDA·Nov 12, 2026·Medartis

Sold nationwide. Siemens is recalling four ARTIS X-ray imaging systems, eight units in total, because they may lose X-ray functionality after the system starts up or restarts. The products are the ARTIS icono biplane, ARTIS icono ceiling, ARTIS icono floor, and ARTIS pheno, distributed in CA, IA, KY, MN, NY, and OH. The notice reports no injuries.

Moderate·FDA·Nov 12, 2026·Siemens4 products

Sold nationwide. Philips is recalling EPIQ and Affiniti diagnostic ultrasound systems with the Auto Measure option running software versions 9.0 or 9.0.1. The software may show incorrect values in the results box, final report, or both, which could mean measurements need to be taken again. No injuries have been reported, and 995 systems are affected.

Moderate·FDA·Nov 12, 2026·Philips

Sold nationwide. Keystone Industries is recalling four FP3D resin cartridges for Carbon 3D printers: FP3D Light Reddish Pink, FP3D Dark Veined, FP3D Original Pink and FP3D Original Opaque. Some cartridges may have been filled without Part B resin. If an affected cartridge is used, the resin may look discolored, and printed parts may be less flexible and durable.

Moderate·FDA·Nov 12, 2026·Keystone Industries4 products

Sold nationwide. Hologic found that some Horizon W and Horizon WI bone densitometers made from December 2024 to January 2025 were shipped without the validated VGA cables. Some of these systems were installed with VGA cables that may not meet Hologic's applicable performance and safety standards. The notice covers 198 units and reports no injuries.

Moderate·FDA·Nov 12, 2026·Hologic

Sold nationwide. 3B Medical is recalling Luna G3 BPAP Systems, a bi-level positive airway pressure device used to treat adult obstructive sleep apnea. When Targeted VT is enabled, the device records and transmits the configured IPAP value instead of the actual inspiratory pressure it delivers.

Serious·FDA·Nov 12, 2026·3B Medical

Sold nationwide. Certain early CMH1530-C-A laser cutting machines have rear service or maintenance doors that are fitted only with key-operated mechanical locks. These machines were not equipped with laser safety interlock devices. The notice reports no injuries.

Moderate·FDA·Nov 12, 2026·Han's Yueming Laser

Sold nationwide. Vitality Works, Inc. is recalling 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha Capsules because they may be contaminated with Salmonella. The product was distributed nationwide, and FDA has classified the recall as Class I. No injuries have been reported.

Serious·FDA·Nov 12, 2026·365 Whole Foods Market

Sold nationwide. Breath of Fresh Air PDX LLC is recalling Ground Up Nut Butter Cups filled with Almond & Cashew Butter Dark Chocolate because they may contain plastic fiber. The product was distributed in Oregon and sold nationwide through online orders. No injuries have been reported.

Moderate·FDA·Nov 12, 2026·Ground Up

Sold nationwide. Boshengya shag area rugs violate the mandatory federal flammability standard for carpets and rugs, posing a risk of serious injury or death from fire. About 83 rugs were sold on Amazon.com from September 2026 through October 2026 for between $30 and $65. No injuries have been reported.

Serious·CPSC·Nov 12, 2026·Boshengya

Sold nationwide. Cummins valves in these portable generators were installed incorrectly, which can stop fuel vapors from venting from the gasoline tank and let pressure build up. This pressure can cause fuel to discharge or the fuel cap to eject, posing a risk of serious injury from fire and burns. The company has received eleven reports of fuel discharging or the cap ejecting, including one person splashed in the face with fuel; no medical attention was needed.

Serious·CPSC·Nov 12, 2026·Cummins

Sold nationwide. The rear wheels on Buzz Bicycles Cerana T2 E-Trike model E4004 can become loose or separate from the rear frame, posing a risk of serious injury from a fall. The firm has received 12 reports of this happening, resulting in three injuries, including shoulder and wrist sprains, leg bruising and abrasions. About 286 units were sold at independent bike shops and online at buzzbicycles.com from November 2024 through July 2026 for between $1,400 and $2,500.

Serious·CPSC·Nov 12, 2026·Huffy

Sold nationwide. Kakgold is recalling about 294 4WD remote-controlled car toys sold on Amazon.com from July through September 2026. The remote control contains button cell and lithium-ion batteries that children can easily access, and the agency says the toys violate the mandatory toy standard. The agency warns that swallowed button cell batteries can cause serious injuries, internal chemical burns and death. No injuries have been reported.

Serious·CPSC·Nov 12, 2026·Kakgold

Sold nationwide. QIOMALA HWT12P pressure washers were sold with a power cord that is too short. The short cord may encourage use of an extension cord, which poses a serious risk of injury or death from shock and electrocution. No injuries have been reported.

Serious·CPSC·Nov 12, 2026·QIOMALA

Sold nationwide. SHEIN Distribution Corporation is recalling baby rattle and teether toy sets that violate the mandatory small parts ban for children under three. The purple and orange knobs can detach from the toys, posing a choking hazard to young children. About 2,657 units were sold on US.Shein.com for about $10.

Serious·CPSC·Nov 12, 2026·Shein

Sold nationwide. Ignited flammable liquid can escape from the fire pits or cause flame jetting from the fuel containers, posing a risk of serious burn and fire injury. The firm has received four reports of ignited fuel escaping during use, resulting in four injuries, including third and fourth degree burns. About 265,000 units were sold nationwide, including at Walmart, Target, Home Depot and Amazon.com, from January 2023 through June 2026 for between $30 and $50.

Serious·CPSC·Nov 12, 2026·Allstar Marketing

Sold nationwide. Medline is recalling 10 convenience kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes, which may be contaminated with a lubricant used in manufacturing. Use of affected wipes may cause localized skin irritation, redness or mild inflammation, and skipping pericare may increase the risk of local infection or catheter-associated urinary tract infection. The kits were distributed in 24 states, and the notice reports no injuries.

Moderate·FDA·Nov 10, 2026·Medline10 products

Sold nationwide. Dev4 is recalling two Eleganz Fusion Screw System products: the 1.8mm cannulated short system (REF DI-2001) and the 1.8mm cannulated drill, long (REF DI-2004). The driver bit included with the screw system may fracture or break during use, which could cause a delay during surgery. No injuries have been reported. The products were distributed nationwide, including in MN, IL, FL, TX, RI, CT, SC and NY.

Moderate·FDA·Nov 10, 2026·Dev42 products

Sold nationwide. Physitemp Instruments is recalling 10 Physitemp temperature monitors and probes, including rectal, esophageal, skin, oral and general-purpose probes and Thermalert monitoring thermometers. The FDA says these devices have not been reviewed for safety and effectiveness for their intended use. The FDA classified the recall as Class II, and no injuries have been reported.

Moderate·FDA·Nov 10, 2026·Physitemp Instruments10 products

Sold nationwide. J F C International Inc. is recalling NAGAI SOYEAT GREEN soy paper wrap because Yellow #5 is not declared on the label. The product was sent to 267 customers nationwide, mainly food service, restaurants, and some deli customers. The recall covers 4,738 units.

Moderate·FDA·Nov 10, 2026·NAGAI SOYEAT GREEN

Sold nationwide. Advagen Pharma is recalling one batch of metoprolol tartrate tablets, 50 mg, in 1,000-count bottles, because of the presence of foreign tablets or capsules. No injuries have been reported.

Moderate·FDA·Nov 10, 2026·Advagen Pharma

Straumann is recalling 2 dental healing abutment products, with 56 units affected: Straumann BLC Implants SLActive WB Healing Abutments and Straumann Healing Abutments, Ti. The recall is for potential exposure to contamination, which may compromise sterility and cleanliness. The notice reports no injuries.

Moderate·FDA·Nov 9, 2026·Straumann2 products