Hawaii recalls

Sold nationwide. Medline Industries distributed 45 tracheostomy tube kits (SKU DYKM2330) with incorrect component labeling. The discrepancy between the kit label and its contents could lead to confusion during use. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Medline

Sold nationwide. Hollister has identified a manufacturing defect in select lots of Onli Hydrophilic Urethral Intermittent Catheters that may cause a protrusion on the catheter tip. This defect could lead to genitourinary trauma or bleeding during use.

Moderate·FDA·Sep 2, 2026·Hollister

Sold nationwide. Medline is recalling specific lots of its medical convenience kits that contain Pilling Wecksorb Neurosponges and Neurosponge Strips. The neurosponges may have endotoxin levels above specification. The recall covers four product groups, about 6,950 kits in total, distributed in several US states. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Medline4 productsExpanded Sep 30

Sold nationwide. Medline is recalling three neonatal and infant heated wire breathing circuit products, about 417,000 units in total. The heated wire connector at the humidifier can fail and show discoloration, melting, smoke, or a burning odor. Failure could cause breathing problems in infants, and no injuries have been reported.

Serious·FDA·Sep 2, 2026·Medline3 products

Sold nationwide. Philips Incisive CT scanners running software versions V4.5 or V5.0 may fail to start a clinical scan during Bolus Tracking imaging procedures. This could delay or prevent necessary diagnostic scans from being acquired.

Moderate·FDA·Sep 2, 2026·Philips

Sold nationwide. Horizon Organic 1% chocolate milk in 8 oz cartons (sold in 12-count and 18-count multipacks) may be spoiled. The affected products have best-by dates between January 28 and February 3, 2027, and were distributed across the United States.

Moderate·FDA·Sep 2, 2026·Horizon Organic

Byron White Formulas is recalling three herbal supplements sold as A-L Complex, A-P, and A-FNG, all in 1.0 fl. oz. (30 mL) bottles. The English labels do not list walnuts, which are in the product, so people with a walnut allergy may not know it is there. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Byron White Formulas3 products

Sold nationwide. ZMB Enterprises' Addall XR Shot 1 liquid dietary supplement contains three undeclared ingredients that are banned or restricted by the FDA: 1,4-DMAA, Phenylethylamine, and Phenibut. The product was sold online between July and December 2025.

Serious·FDA·Sep 2, 2026·Addall XR

Khong Guan is recalling two sizes of its glutinous rice balls with black sesame filling, 14.1 oz (400 g) each, because they may contain peanuts that are not listed on the label. The recall covers two UPC products, both made in China and sold in AZ, CA, CO, HI, NJ, OR, TX and WA. No illnesses have been reported.

Serious·FDA·Sep 2, 2026·Khong Guan2 products

Sun Noodle's Sura Tanmen Hot and Sour Flavor ramen noodle kit contains a soba sauce packet with fish (bonito, sardine, and mackerel), but the package label does not disclose these fish allergens. This poses a risk to people with fish allergies. About 140 packages were distributed in Hawaii.

Serious·FDA·Sep 2, 2026·Sura

Sold nationwide. B. Braun Medical has recalled Lactated Ringer's Injection USP in 1000 mL EXCEL containers due to the presence of particulate matter. The affected lot is J4H077 with an expiration date of November 30, 2026. About 23,688 bags were distributed nationwide.

Serious·FDA·Sep 2, 2026·B. Braun

Sold nationwide. Hikma Pharmaceuticals is recalling specific lots of Ramipril Capsules 10 mg because testing found higher-than-allowed levels of dicyclohexylurea, a process impurity. The affected lots are AC5470A and AC5470B, both expiring July 2027. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Hikma Pharmaceuticals

Sold nationwide. Fresenius Kabi USA discovered that Tyenne (tocilizumab-aazg) Injection vials may contain glass particles. The contamination was found during an internal investigation. The affected lot is 16UI07, which expires August 31, 2028.

Serious·FDA·Sep 2, 2026·Fresenius Kabi

Sold nationwide. Apotex Corp. is recalling one lot of Paxil CR (paroxetine) 37.5mg extended-release tablets because the medication failed to meet dissolution specifications during 24-month stability testing. This means the tablets may not release the drug into the body as intended. The affected lot (TY9494, expiration 05/31/2027) was distributed nationwide.

Moderate·FDA·Sep 2, 2026·Apotex

Sold nationwide. Mallinckrodt has recalled specific lots of Acthar Gel (repository corticotropin injection) due to the presence of glass and stopper pieces in the vials. This contamination could pose a risk if the affected medication is used. The recall affects 12,367 vials with lot numbers 1564-107 and 1564-107H, both expiring January 31, 2027.

Moderate·FDA·Sep 2, 2026·Mallinckrodt

Sold nationwide. FDA inspection found that Zicam Cold Remedy Medicated Nasal Swabs failed microbiological testing, meaning they may contain harmful microbes. The affected products were manufactured under conditions that did not meet federal safety standards. Specific lot numbers with expiration dates through August 2028 are involved.

Moderate·FDA·Sep 2, 2026·Arm & Hammer

Sold nationwide. Lupin Pharmaceuticals is recalling specific lots of Clobetasol Propionate Cream USP 0.05% because the active ingredient is not uniformly distributed throughout the product. This means some parts of the cream may contain too much or too little medication, which could affect how well it works.

Moderate·FDA·Sep 2, 2026·Lupin

Sold nationwide. Accord Healthcare is recalling specific lots of levothyroxine sodium tablets (25 mcg) because they contain less active ingredient than labeled. Patients taking these tablets may not receive the full dose needed to manage their thyroid condition. The affected lots were distributed nationwide.

Moderate·FDA·Sep 2, 2026·Accord Healthcare12 products

Sold nationwide. Northwest Naturals has recalled two frozen raw pet food products because they may be contaminated with Salmonella and/or Listeria monocytogenes. The affected products are the Frozen Chicken Recipe (cat food, 2 lb. bags) and Frozen Raw Diet for Dogs Chicken Recipe (6 lb. bags) in specific lots. No illnesses have been reported so far.

Serious·FDA·Aug 29, 2026·Northwest Naturals

Sold nationwide. B. Braun Medical Inc. is recalling three lots of 0.9% Sodium Chloride Injection (saline solution) used in hospitals and healthcare settings. The recalled product contains particles of zinc oxide that should not be present. Intravenous fluids contaminated with particulate matter can cause serious complications including blood clots and organ damage. No injuries have been reported so far.

Serious·FDA·Aug 27, 2026·B. BraunUpdated Sep 3

Sold nationwide. Lipofit Extreme Fat Burner 2.0 (Lot 25M12F, expiration 09/2027) contains undeclared fluoxetine, a prescription antidepressant, in the daytime tablets and undeclared 2,4-dinitrophenol (DNP), a toxic pesticide, in the nighttime tablets. Neither ingredient is approved for use in dietary supplements, and DNP is not approved by the FDA for any use in humans.

Serious·FDA·Aug 27, 2026·Lipofit

Sold nationwide. Revival Animal Health recalled Breeder's Edge® and Shelter's Choice® Feline Milk Replacers because some batches contain low levels of potassium, copper, folic acid, choline, and/or vitamin B6. Young kittens depend entirely on milk replacer for nutrition, and these deficiencies can cause anemia, organ damage, and developmental problems within days or weeks.

Serious·FDA·Aug 26, 2026·Revival Animal Health

Sold nationwide. Baxter is recalling one lot of Anticoagulant Sodium Citrate Solution used with apheresis devices due to potential fiberglass particles in the solution. The affected product was distributed to one customer in the United States between July 2 and July 11, 2026. No adverse events have been reported to date.

Moderate·FDA·Aug 26, 2026·Baxter

Sold nationwide. American Contract Systems is recalling 2 lines of medical procedure kits and trays, 4,949 kits in total, distributed in Minnesota, Missouri, and Iowa. The recall follows Medicom's recall of specific lots of Ritmed Neurological Sponges, which may have unexpectedly variable endotoxin levels. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·American Contract Systems2 products

Sold nationwide. restor3d Inc. is recalling specific lots of the Veritas Standard Glenoid Baseplate used in reverse shoulder replacement surgery. A manufacturing error created incorrectly machined screw holes that may prevent peripheral screws from engaging properly during surgery. The defect affects only the standard baseplate; patient-specific baseplates are not affected.

Moderate·FDA·Aug 26, 2026·Restor3d

Sold nationwide. ConvaTec's Esteem Body Soft Convex Urostomy Pouches may leak from the cap during normal use. This affects multiple model numbers distributed nationwide across the U.S. No injuries have been reported to date.

Moderate·FDA·Aug 26, 2026·ConvaTec

Sold nationwide. Fort Defiance Industries is recalling its Automated Field Steam Sterilizer because the 120V connector on the water recovery system may intermittently lose its ground connection. This could make the electrical fault current path unreliable. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Fort Defiance Industries

Sold nationwide. Medtronic is recalling three MiniMed insulin pump models (640G, 670G, and 780G) that were loaned out and may have been cleaned with products that are incompatible with the pump. This could damage the case or keypad, let moisture in, and cause the pump to deliver too much or too little insulin. No injuries have been reported. The recall covers 280 affected pumps and was distributed in several European countries.

Moderate·FDA·Aug 26, 2026·Medtronic3 products

Sold nationwide. BMC Medical Co., Ltd. is reporting retroactive rework that was conducted on Luna G3 APAP devices at the 3B/React Health warehouse in 2024. This retroactive reporting involves approximately 20,160 units with specific serial numbers.

Serious·FDA·Aug 26, 2026·BMC Medical

Sold nationwide. Boston Scientific is recalling two ENROUTE Transcarotid Neuroprotection System products: the standard system (Material Number SR-200-NPS) and the Plus system (SR-250-NPS). The recall covers about 164,700 units, distributed in the US and to Australia, Canada, China and Jamaica. The arterial sheath tip may separate, fully or partially, during use. No injuries have been reported.

Serious·FDA·Aug 26, 2026·Boston Scientific2 products