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Certain NeuroStar Advanced Therapy System units contain coil assembly cables that do not meet product specifications. The affected coil assemblies are identified by specific serial numbers. This defect could affect the device's performance or reliability during treatment.

Moderate·FDA·Oct 21, 2026·Neuronetics

The IOMAX Cortical Module, a medical device used for electrical stimulation testing, contains a defective printed circuit board that may cause the device to deliver electrical stimulation to a patient unintentionally or allow unwanted electrical current to reach the patient. The issue affects 23 devices with specific serial numbers distributed in the US and internationally.

Serious·FDA·Oct 21, 2026·Cadwell

Becton Dickinson's Phoenix Panel NMIC-312 (Catalog Number 449082) may produce inaccurate results when testing Klebsiella pneumoniae using the CPO Ambler classification feature. This could cause quality control checks to fail undetected in clinical laboratories.

Moderate·FDA·Oct 21, 20262 products

Medtronic found that the donor tissue used in batch A62881 did not meet its microbial screening requirements, and donor bone tested positive for Clostridium butyricum. Although the tissue was gamma irradiated and the finished batch passed sterility testing, implanting it could lead to a Clostridium infection. The recall covers two products, and no injuries have been reported.

Moderate·FDA·Oct 21, 20262 products

The Jenavalve Trilogy Delivery Catheter (Size 23MM, REF: TRILOGY-DC-S) may experience separation of the sleeve liner, which could make it difficult or impossible to deploy the heart valve device during the procedure. The FDA has classified this as a Class II recall.

Moderate·FDA·Oct 21, 2026·Jenavalve3 products

Instrumentation Laboratory is recalling two part numbers of the HemosIL AcuStar HIT-IgG(PF4) in vitro diagnostic test, 1,848 units in total. The test may produce an invalid calibration curve, or patient results may read up to 47% lower than they should. The recall covers US states and countries worldwide. No injuries have been reported.

Serious·FDA·Oct 21, 20262 products

Primal Herbs Volume, sold as a herbal supplement, contains sildenafil—a prescription medication—that is not listed on the label. FDA testing confirmed the presence of this undeclared ingredient. The product was sold online between July 2 and September 19, 2025.

Serious·FDA·Oct 21, 2026·Primal Supplements

Par Health USA's Dexmedetomidine HCl injection vials contain unwanted particulate matter, identified as cellulose or stopper material. The contamination affects two specific lots distributed nationwide. This is a prescription medication used during anesthesia and sedation.

Serious·FDA·Oct 21, 2026

American Health Packaging distributed metoclopramide 5 mg tablets that contained foreign tablets or capsules mixed in with the correct medication. The contamination was found in two lot numbers distributed nationwide. No injuries have been reported.

Moderate·FDA·Oct 21, 2026·American Health Packaging

Houston Rx is recalling two injectable products, a tirzepatide/niacinamide 2 mL vial and a sermorelin 10 mL vial, because the company cannot assure they are sterile. The recall covers 71 vials distributed nationwide in the USA, and the FDA has reported no injuries.

Moderate·FDA·Oct 21, 2026·Houston Rx2 products

Zydus Pharmaceuticals is recalling specific lots of Hydrocortisone Sodium Succinate for Injection because the drug failed quality testing for impurities and degradation. The affected lots (LB00047A and LB00048A, expiring 03/2028) were distributed nationwide. No injuries have been reported.

Moderate·FDA·Oct 21, 2026

Teva Pharmaceuticals discovered that some bottles of Metoclopramide 5 mg tablets contain foreign tablets or capsules mixed in with the correct medication. The contamination was found in specific lots distributed nationwide. No injuries have been reported.

Moderate·FDA·Oct 21, 2026

Ventec Life Systems is recalling 12 ventilator products used for ventilatory support, including VOCSN+Pro, VC+Pro, VOCSN, VCSN+Pro, V+Pro, VC, V+ Pro Emergency and V*Home models, plus Japan versions. The flow transducer cable connector can disconnect from an internal board, which may cause the system to reboot and interrupt ventilation therapy. The recall covers US distribution and Japan and China, and no injuries have been reported.

Serious·FDA·Oct 20, 202612 products

Right Value Drug Stores LLC is recalling compounded testosterone cypionate injection (200 mg/mL) in 5 mL and 30 mL vials due to lack of sterility assurance. The affected vials were distributed nationwide to medical offices. No injuries have been reported.

Moderate·FDA·Oct 19, 2026·Right Value Drug Stores LLC

Ashtel Studios Inc. of Ontario, California is recalling 17 fluoride toothpaste products nationwide because they were made in ways that did not meet FDA manufacturing standards. The products are sold under the Barbie, Hot Wheels, Crayola and My Little Pony names, plus the Brush Buddies, evo, ARU and BB brands. No injuries have been reported.

Moderate·FDA·Oct 19, 2026·PRITAM INTERNATIONAL PRIVATE LIMITED17 products

Philips Smart-hopping 2.0 AP wireless access points may experience unreliable roaming behavior when older Smart-hopping 1.0 wireless clients move between locations. This can cause loss of connection to the central monitoring system, potentially interrupting patient monitoring in healthcare facilities.

Moderate·FDA·Oct 16, 2026

Axonics has recalled certain lots of its PNE Lead Implant Kit because the 10mL luer lock syringes included in the kit may leak, break, or malfunction. This could affect the safe use of the implant procedure. The recall affects approximately 18,294 kits distributed nationwide and internationally.

Moderate·FDA·Oct 16, 2026·Axonics

Medtronic Navigation is recalling four products: certain NDI passive spheres and a biopsy needle kit. The reflective material on these items may vary, which could affect a navigation system's ability to detect and track them. No injuries have been reported.

Moderate·FDA·Oct 16, 20264 products

B. Braun Medical Inc is recalling certain SAFSITE Injection Site valves (model RV1000NC, catalog number 415068) because they may leak or allow blood to flow backward into the IV line. This could affect the safety of IV therapy. The recall affects specific lot numbers with expiration dates in September and October 2029.

Moderate·FDA·Oct 16, 2026

Think Surgical's Square Driver robotic component did not meet design specifications. This could cause the pin to become stuck or wobble during surgical drilling procedures. No injuries have been reported.

Moderate·FDA·Oct 16, 2026·Think Surgical

Abbott has updated the instructions for use for certain Amplatzer Amulet left atrial appendage occluder devices to address a risk of pulmonary artery injury during the procedure. This is a precautionary update affecting multiple model numbers across all lots and serial numbers.

Moderate·FDA·Oct 16, 2026

The Philips Lumify portable ultrasound system may fail to recognize previously saved transducer settings, forcing re-registration that requires Wi-Fi or cellular access—unavailable in ambulances, aircraft, or remote field settings. Additionally, the USB cable connection between the transducer and tablet/phone may become unstable or disconnect, disrupting scans. These issues could delay diagnosis or treatment.

Serious·FDA·Oct 16, 2026

Pfizer is recalling specific lots of Levoxyl (levothyroxine sodium) 175 mcg tablets because stability testing found the drug potency fell below required specifications. This means some tablets may contain less active medication than labeled. The recall affects 134 bottles with lot number 24W07, expiring 11/30/2026.

Moderate·FDA·Oct 16, 2026·Pfizer2 products

Hepalink USA is recalling Heparin Sodium Injection (5,000 USP Units/mL) due to lack of assurance that the product is sterile. The affected multidose vials have lot number CU03232A with an expiration date of January 31, 2028. This product is used in hospitals and medical settings.

Moderate·FDA·Oct 16, 2026·Techdow

Certain lots of Telmisartan and Amlodipine 40mg/5mg tablets manufactured by Mylan Pharmaceuticals (Viatris) may contain higher-than-specified amounts of Telmisartan, the blood pressure-lowering active ingredient. The affected lots were distributed nationwide. No injuries have been reported.

Moderate·FDA·Oct 16, 2026·Viatris

Ascend Laboratories is recalling one lot of amlodipine and olmesartan medoxomil combination tablets (10mg/40mg) because they do not dissolve properly in the body. This means the medication may not work as intended. The affected lot was distributed nationwide.

Moderate·FDA·Oct 16, 2026

Intellijoint Surgical's orthopedic navigation workstations may contain a 15-inch MacBook Pro battery that is subject to an Apple recall. The battery may overheat and pose a fire safety risk during use in surgical settings.

Moderate·FDA·Oct 14, 2026

A software issue in Steris HexaVue Focus Integration System (version 2.0.18) can cause incorrect patient information to appear on manually printed surgical images. This mismatch could lead to documentation errors or clinical images being linked to the wrong patient record.

Moderate·FDA·Oct 14, 2026

LeMaitre Vascular's TufTex Over-the-Wire Embolectomy Catheter (Catalog Number E1651-88, Lot XOT00002181) failed internal testing. The balloon components can fail when exposed to pull force during use, which could compromise the device's ability to remove blood clots safely.

Moderate·FDA·Oct 14, 2026

Mindray is recalling 8 patient and telemetry monitor product lines because some operator's manuals may be insufficient or unclear about certain physiological alarm functions. The FDA classified this as a Class III recall, and no injuries have been reported. About 275,000 units are affected across the included models.

Moderate·FDA·Oct 14, 20268 products