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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, 20264 products

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, 20263 products

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, 202613 products

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, 20262 products

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

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, 202616 products

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

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, 20263 products

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, 20264 products

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

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

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

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

Chiesi USA, Inc. is recalling Revcovi (elapegademase-lvlr) Injection due to out-of-specification stability results in the protein concentration profile. The affected lot was distributed to Missouri and Tennessee. No injuries have been reported.

Moderate·FDA·Sep 9, 2026

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

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

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

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

The FDA recall covers two Broadway Joe's pain creams containing CBD and hempseed oil, sold in 2 oz and 4 oz jars. The recall was made because of possible contamination of a raw material, found through manufacturing quality issues. The products were distributed in Colorado, and no injuries have been reported.

Moderate·FDA·Sep 9, 2026·Lexia2 products

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

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

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, 202617 products

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, 20262 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

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

GE is recalling four Portrait Core Services software products because a software issue may cause a loss of patient monitoring at the Hub and Central Viewer. After the update, alarm settings may also reset to factory defaults and no longer match the settings configured for each patient or care area. No injuries have been reported.

Serious·FDA·Sep 2, 20264 products

Olympus Corporation of the Americas is recalling POWERSEAL 5mm curved jaw sealer and divider devices due to incorrect labeling on the outer box. Some units labeled as 37 cm devices actually contain 23 cm devices, which could lead to confusion during surgical use. The issue affects 335 units distributed in the US, Australia, the European Union, and Japan.

Moderate·FDA·Sep 2, 2026

IMRIS is recalling 2 operating room table models, the ORT200 and ORT300, with 19 affected units. A mechanical failure in the linear actuator and rotational lock can stop the table from switching between locked and unlocked, which could allow unintended rotation during a procedure. No injuries have been reported.

Serious·FDA·Sep 2, 2026·IMRIS2 products

Healthmark Industries is recalling two ProChek protein test products, 5,143 units in total. The tests were made with an expired ingredient, so they may give false negative or false positive results. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Healthmark Industries2 products

FUJIFILM Synapse PACS software version 7.4.310, used in radiological imaging systems, has a software issue that can cause the ruler measurement tool to display inaccurate values. This affects 6 units distributed across select US states and Australia. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Fujifilm