Montana recalls

Sold nationwide. Par Pharmaceutical is recalling two lots of dexmedetomidine HCl injection used in hospitals for patient sedation. The vials contain unwanted particles of cellulose or stopper material that could cause serious blood vessel blockages or clotting if injected into patients. No patient injuries have been reported so far.

Serious·FDA·Sep 18, 2026·Par Health

Sold nationwide. One lot of ICU Medical 0.9% Sodium Chloride Injection (a salt solution) was found to contain 10 mEq Potassium Chloride Injection instead. The vial had the correct outer label but the wrong product inside. This was discovered through a customer complaint.

Serious·FDA·Sep 17, 2026·ICU Medical

Sold nationwide. These translucent green squishy toys contain water beads that expand larger than the legal safety limit. If a child ingests a water bead, it can cause choking, intestinal blockage, vomiting, dehydration, and potentially death.

Serious·CPSC·Sep 17, 2026·Toyworld168

Sold nationwide. Tongyang Cycling's Basecamp model HT-10 bicycle helmets do not meet federal safety standards for impact protection and stability, and may fail to protect your head in a crash. The helmets also contain button cell batteries without required warning labels, creating a poisoning risk if swallowed.

Serious·CPSC·Sep 17, 2026·Tongyang Cycling

Sold nationwide. The infrared heating panels in Sauna360 saunas and kits can short circuit and overheat, creating a risk of fire and serious burns. The company has received 67 reports of overheating, melting, charring, or burning, though no injuries have been reported yet.

Serious·CPSC·Sep 17, 2026·Sauna360

Sold nationwide. The bench seating in Sauna360's Tylö Halmstad and Kiruna Hybrid sauna rooms can collapse, creating a fall hazard. A previous repair offered in October 2025 did not fully resolve the problem. Sauna360 has received 77 reports of bench failures, resulting in six injuries.

Serious·CPSC·Sep 17, 2026·SFactor

Sold nationwide. SHEIN is recalling Pull and Chew Montessori Teething Toys because the silicone strings are longer and smaller than safety standards allow. The strings can reach the back of a child's throat and become lodged, creating a serious choking risk.

Serious·CPSC·Sep 17, 2026·Shein

Sold nationwide. Regfear's BedsPick brand mattresses (12-inch queen size, sold compressed in boxes) fail to meet mandatory federal flammability standards, creating a risk of fire-related injury or death. The mattresses have a white top with either purple or gray sides and were sold on Amazon between February 2025 and May 2026.

Serious·CPSC·Sep 17, 2026·Regfear

Sold nationwide. The black plastic fire hose port on this toy fire truck can come loose and detach, creating a choking hazard for young children. Melissa & Doug has received 26 reports of the port detaching and one report of a minor cut. The toy was sold at Target stores and online from July 2025 through August 2026.

Serious·CPSC·Sep 17, 2026·Melissa & Doug

Sold nationwide. LANCHEZ-branded electric pressure washers lack a ground-fault circuit-interrupter (GFCI) and have a short power cord, which may lead users to rely on extension cords. This creates a serious risk of electric shock or electrocution. About 329 units were sold online between February and June 2026.

Serious·CPSC·Sep 17, 2026·Lanchez

Sold nationwide. The heating elements inside JKMAX branded heated blankets and pads can overheat, causing the products to smoke, melt, or catch fire. The company has received 577 reports of overheating, including 53 burn injuries.

Serious·CPSC·Sep 17, 2026·Jiande Pengshuai

Sold nationwide. Hayward-branded HDFS400 Universal-HC Series pool heaters can produce dangerously high levels of carbon monoxide during operation, which may cause serious injury or death. About 4,600 of these 400,000 BTU dual-fuel heaters were sold between March and July 2026.

Serious·CPSC·Sep 17, 2026·Hayward

Sold nationwide. The control board inside the motor of certain Friedrich KÜHL Q and KÜHL S window air conditioners can fail, causing the motor to ignite. The company has received two reports of motors catching fire, including one incident that caused smoke and fire damage to a home.

Serious·CPSC·Sep 17, 2026·Friedrich

Sold nationwide. Red knobs on the Esjay Toddler Busy Board can detach, posing a choking risk for children under three. The toy violates federal small parts safety rules. No injuries have been reported, but the hazard is serious.

Serious·CPSC·Sep 17, 2026·Esjay US

Sold nationwide. These 30-piece magnetic toy sets contain high-powered magnets in the hands and feet that can come loose and be swallowed by children. When multiple magnets are ingested, they can attract each other inside the digestive system, causing serious injuries including intestinal perforation, blockage, and blood poisoning. Two children have already been hospitalized after removing and swallowing magnets from these toys.

Serious·CPSC·Sep 17, 2026·Colerinsec

Sold nationwide. The grounding wire inside these electric grills can disconnect from the heating element, which removes a safety layer that normally protects against electric shock. This affects specific models made between October and December 2025. No injuries have been reported.

Moderate·CPSC·Sep 17, 2026·Char-Broil

Sold nationwide. Windstone Medical Packaging's AMS Convenience Kit DSAEK Pack contains saline solution bags with blue connector pieces that may detach from the infusion port during normal use. This could allow contamination or improper fluid delivery during ophthalmic surgery.

Serious·FDA·Sep 16, 2026·Windstone Medical Packaging

Sold nationwide. Nipro is recalling four hemodialysis concentrate products because they may contain high levels of endotoxin, a substance from bacteria. The recall covers about 13,000 cases and 100 drums across the US, Guatemala, and Panama, with US distribution in FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA. No injuries have been reported.

Serious·FDA·Sep 16, 2026·Nipro4 products

Sold nationwide. HeartSine Technologies has recalled certain models of the SAM 350P, SAM 360P, and SAM 450P public access defibrillators (PADs) due to a damaged membrane component that can cause an intermittent electrical fault. The fault could prevent the device from operating properly when needed in a cardiac emergency. Approximately 11,912 affected units have been identified by serial number.

Serious·FDA·Sep 16, 2026·HeartSine

Sold nationwide. Bard is recalling six Foley and intermittent catheter tray products because the pericare wipes packed with them may have contamination on their surface. The recall followed customer complaints, and no injuries have been reported. The trays were distributed across the United States and in several other countries.

Moderate·FDA·Sep 16, 2026·Bard6 products

Sold nationwide. Atrium Medical is recalling three Getinge PVC thoracic catheter products, covering 11 model sizes, from a single lot. Testing found bacterial endotoxin levels above the allowed limit. No injuries have been reported.

Moderate·FDA·Sep 16, 2026·Atrium Medical3 products

Sold nationwide. Lutronic's DermaV laser system may produce sparks and loud noise when used at higher energy levels (fluences) at the 1064 nm wavelength with current cooling settings. This spark hazard could result in patient burns during treatment.

Moderate·FDA·Sep 16, 2026·Lutronic

Sold nationwide. Halyard IV Start Kit Non-Sterile (REF: KRIV26-02) convenience kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkles in the paper lidding that may breach the seal. This compromises sterility assurance of the applicators. 98 kits in lot 1658438 (expiration 7/31/2026) were distributed nationally.

Moderate·FDA·Sep 16, 2026·AVID MedicalExpanded Sep 30

Sold nationwide. The Bravo CF capsule delivery device is used during esophageal pH monitoring procedures to attach a small capsule to the esophagus. The capsule may fail to attach properly or detach from the delivery device during use. This can result in the capsule being inhaled, perforating the esophagus, blocking the airway, or causing bleeding.

Serious·FDA·Sep 16, 2026·Given Imaging

International Sprout Holdings' alfalfa product (50 lb. bags, Lot SAL2-24JB) has been recalled due to potential E. coli and Salmonella contamination. The affected product was distributed wholesale to food service operators and retailers across 16 U.S. states, Puerto Rico, Canada, Mexico, Tahiti, and Venezuela.

Serious·FDA·Sep 16, 2026·International Specialty Supply

Sold nationwide. L-Nutra Inc's Prolon Everyday Apulian Almond & Cocoa Spread contains undeclared hazelnut, cashew, and pistachio allergens. The product was sold online nationwide in 8-ounce glass jars (Lot L2755, expiring January 2, 2027).

Moderate·FDA·Sep 16, 2026·Prolon

Sold nationwide. Momchipz Gluten Free Veggie Chips (Broccoli Florets & Cauliflower, 3 oz) contain undeclared wheat, which is not listed on the package label. The product was sold in the U.S. and imported from Indonesia. People with celiac disease or wheat allergy are at risk.

Serious·FDA·Sep 16, 2026·Momchipz

Sold nationwide. B. Braun Medical Inc. is recalling specific lots of 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide, inorganic material, cellulose fibers, and polystyrene. The contamination was identified during quality testing. This is a sterile injectable product distributed nationwide.

Serious·FDA·Sep 16, 2026·B. Braun

Sold nationwide. American Regent's epinephrine injection (1 mg/mL, 30 mL vials) may contain particulate matter—including nylon, glass, and other materials—and some vials are broken or leaking. This affects the sterility and safety of the medication. Three specific lot numbers distributed nationwide are involved.

Serious·FDA·Sep 16, 2026·American Regent

Sold nationwide. OurPharma LLC's fentanyl citrate 1,000 mcg injection solution has conflicting expiration dates printed on the IV bag and product labeling. The bag shows expiry dates of 07/31/2026 or 11/30/2026, while the product itself is labeled as expiring 12/09/2026. This discrepancy could lead to confusion about when the medication is safe to use.

Moderate·FDA·Sep 16, 2026·OurPharma