Alaska recalls

Sold nationwide. Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.

Moderate·FDA·Sep 9, 2026·Fresenius Medical Care3 products

Sold nationwide. Specific lots of B Braun's Discofix Four Way Stopcock extension sets have an incorrect expiration date printed on the carton shipper label. This labeling error could affect proper product tracking and usage verification.

Moderate·FDA·Sep 9, 2026·B. Braun

Sold nationwide. A software issue in the robotic controller of the Medos Velys Enabling Tech Robotic-Assist Station may cause the robotic arm to move unexpectedly during bone preparation or instrument positioning in orthopedic surgery. This affects 29 devices nationwide.

Moderate·FDA·Sep 9, 2026·Medos

Sold nationwide. Fresenius Medical Care is recalling four 5008X blood tubing set models because the connection between the Arterial Alpha Clip and the main line or pump segment may leak blood during treatment. A leak could cause blood loss and low blood volume. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Fresenius Medical Care4 products

Sold nationwide. Boston Scientific is recalling server software that supports its LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors. The recall covers three products, one for each region: US, EU, and ANZ. The software can delay notifications of AF Burden Alerts, which are alerts about atrial fibrillation, and a delayed alert may delay clinical review or treatment. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Boston Scientific3 products

Sold nationwide. Medline is recalling 13 convenience kits that contain BD ChloraPrep Clear 1mL applicators from specific lots. The applicator packaging may have an open or incomplete seal, so the applicator could be contaminated. Contaminated applicators can cause skin or soft tissue infections, or more serious infections, and no injuries have been reported.

Moderate·FDA·Sep 9, 2026·Medline13 products

Sold nationwide. Baxter is recalling two Novum IQ syringe pump models, totaling about 14,605 units. During a Volume/Time (VOT) multi-syringe infusion, a software issue may occur if a syringe runs empty and is replaced while the Volume To Be Infused (VTBI) is still remaining. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Baxter2 products

Sold nationwide. Johnson & Johnson is sending updated surgical instructions for HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used in cataract surgery. The new instructions emphasize that if resistance is felt when inserting the cannula, surgeons should stop, withdraw the cannula, and reassess insertion conditions rather than forcing it—to avoid potential injury to the cornea, iris, or Descemet's membrane (a delicate eye structure).

Moderate·FDA·Sep 9, 2026·Johnson & Johnson Surgical Vision

Sold nationwide. Medline is recalling 16 convenience kit products that contain BD ChloraPrep Clear or FREPP Clear antiseptic applicators. Wrinkles in the paper lidding may extend to the seal, which could break the sterile packaging and allow microbial contamination. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Medline16 products

Sold nationwide. Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.

Moderate·FDA·Sep 9, 2026·Diagnostica Stago

Sold nationwide. Medicom is recalling specific lots of Ritmed Neurological Sponges (non-sterile models 55992C to 55998C) because their endotoxin levels may vary unexpectedly. AVID Medical is recalling three groups of Halyard medical convenience kits that contain these sponges, about 28,800 kits in total. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·AVID Medical3 products

Sold nationwide. Philips is recalling four CT scanner product lines, covering 4 product groups, because an unintended radiation issue could affect how the equipment performs. The recall covers Philips Brilliance, IQon Spectral CT, Ingenuity CT, and Brilliance CT 64 systems distributed in the US and US territories. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Philips4 products

Sold nationwide. Savor Seasonings LLC's bulk Organic Cheddar Type Seasoning tested positive for milk allergen that was not listed on the label. The affected product is packaged in 50-lb bags and distributed in Canada. This poses a serious risk to people with milk allergies.

Serious·FDA·Sep 9, 2026·Savor Seasonings

Sold nationwide. The Hampton Grocer's Lacnola Small Batch Lactation Granola (8 oz pouches) may be contaminated with Salmonella. Two specific lot codes are affected: HGLC-102125 (expires 21 Oct 2026) and HGLC-021326 (expires 13 Feb 2027).

Serious·FDA·Sep 9, 2026·The Hampton Grocer

Sold nationwide. Optimal Balance Pharmacy's Glutathione 200 mg/mL injectable solution failed quality testing and was found to contain bacterial endotoxin levels above safe limits. This contamination poses a risk of serious infection or systemic reaction when injected. The affected lot (LG342009076) was distributed nationwide.

Serious·FDA·Sep 9, 2026·Optimal Balance Pharmacy

Sold nationwide. Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP in 500 mL VIAFLEX plastic containers because some bags contain fiberglass particles. The affected lots are Y495523 and Y495523A, expiring October 31, 2027. No injuries have been reported.

Serious·FDA·Sep 9, 2026·Baxter

Sold nationwide. American Health Packaging distributed buprenorphine sublingual tablets with incorrect labeling. The affected medication is a prescription opioid used to treat pain and opioid use disorder. A label mix-up could result in dosing errors if patients or healthcare providers rely on incorrect information.

Moderate·FDA·Sep 9, 2026·American Health Packaging

Sold nationwide. Mylan Pharmaceuticals is recalling Prasugrel 10mg tablets (Lot #3225272, expiring September 30, 2026) because they failed dissolution testing during 18-month stability studies. This means the tablets may not break down and release the medication as intended in the body. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Mylan

Sold nationwide. Sage Products is recalling specific lots of 2% Chlorhexidine Gluconate non-sterile cloths due to potential cross-contamination with other products during manufacturing. The affected cloths may not meet safety and quality standards. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Sage Products

Sold nationwide. Teva Pharmaceuticals discovered that some bottles of trazodone 50 mg tablets contain foreign tablets or capsules mixed in with the correct medication. The issue affects one lot (1394026) with an expiration date of February 2028. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Teva

Sold nationwide. Supernus Pharmaceuticals is recalling one lot of Trokendi XR (topiramate) 50 mg extended-release capsules because the medication did not dissolve as designed. When a medication fails to dissolve properly, the body may not absorb the full dose, potentially reducing its effectiveness.

Moderate·FDA·Sep 9, 2026·Supernus

Sold nationwide. Mylan Pharmaceuticals is recalling specific lots of Mycophenolate Mofetil for injection (500 mg/vial) because the medication failed to meet dissolution specifications—meaning the drug may not dissolve properly in the body. This could affect how well the medicine works. The recall affects two lots distributed nationwide.

Moderate·FDA·Sep 9, 2026·Mylan

Sold nationwide. Allies is recalling four sizes of THE ONE SPF 50 Invisible Sunscreen Gel, sold as 3 mL sachets, 20 mL, 50 mL and 90 mL tubes. Testing found the product may not reliably provide the SPF 50 protection stated on the label. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Allies4 products

Sold nationwide. Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets (10 mg/10 mg, 100-count bottles) because some bottles contain unidentified foreign tablets or capsules mixed in with the correct medication. The affected lot is DMA25006 with an expiration date of 11/30/2028. This issue was discovered during quality control.

Moderate·FDA·Sep 9, 2026·Bionpharma

Sold nationwide. Baxter is recalling 17 intravenous (IV) drug products for manufacturing quality problems, called CGMP deviations, which are lapses in the required production standards. The products include vancomycin, daptomycin, clindamycin, famotidine, dexmedetomidine, vasopressin, pantoprazole, insulin, nicardipine, and amiodarone, plus the brand names Myxredlin, CARDENE IV, and Nexterone. They were distributed nationwide, in Puerto Rico, and in Chile, and no injuries have been reported.

Moderate·FDA·Sep 9, 2026·Baxter17 products

Sold nationwide. Golden State Medical Supply Inc. is recalling Prasugrel HCI 10mg tablets (lot GS062298, expiration 09/30/2026) because they failed to meet dissolution specifications during quality testing. Dissolution is how quickly a tablet breaks down in the body to release its active ingredient. Tablets that dissolve too slowly or incompletely may not work as intended.

Moderate·FDA·Sep 9, 2026·Golden State Medical Supply2 products

Food to Live Organic SuperGrass Powder in 6 oz, 12 oz, 1 lb, and 4 lb containers has been recalled due to Salmonella contamination. The affected products were distributed across the United States and U.S. Virgin Islands. No illnesses have been reported.

Serious·FDA·Sep 9, 2026·Food to Live

Sold nationwide. BMC Medical Co., Ltd. recalled 20,160 Luna G3 APAP sleep apnea devices (Model LG3600) due to a firmware defect in version G3-2.00.76. Under certain high-pressure, high-breathing-rate conditions, affected devices can display an error message and shut down automatically, stopping therapy delivery. Most devices were corrected with a firmware upgrade, but up to 196 units may still contain the defective version.

Serious·FDA·Sep 7, 2026·BMC Medical

Sold nationwide. SUPPLX.com's Business Pill and Branch Manager for Men dietary supplements contain yohimbine that is not listed on the labels. FDA testing found dangerously high levels of this substance, which can cause serious heart problems, severe high blood pressure, and other dangerous side effects—especially in people taking stimulants or certain medications.

Serious·FDA·Sep 3, 2026·Supplx.com

Sold nationwide. American Regent is recalling three lots of epinephrine injection (1 mg/mL multi-dose vials) due to leaking and cracked vials, plus contamination with particles including nylon, cellulosic, acrylic, polyethylene, and glass. These particles can block blood vessels, cause blood clots, and damage organs; cracked vials also risk loss of sterility and bacterial contamination. No adverse events have been reported so far.

Serious·FDA·Sep 3, 2026·American Regent