Kansas recalls

Sold nationwide. Some LeadCare II Blood Lead Test Kits (model 70-6762, sub-lot 2530M-01) have an incorrect expiration date printed on the outer label. The label shows July 22, 2026, but the correct date is July 13, 2026. When used after the correct expiration date, the system will display an error and prevent the test from running, causing delayed results.

Moderate·FDA·Oct 21, 2026·Magellan Diagnostics

Sold nationwide. Beckman Coulter is recalling DxU 840m and 850m Iris analyzers and several IQ200 Sprint, Select, and Elite analyzer models. The rinse-line check valve on these instruments wears out sooner than expected and needs yearly replacement, but that step was left out of the required preventive maintenance schedule. If the valve is not replaced, lamina fluid can leak onto the table or floor, and no injuries have been reported.

Moderate·FDA·Oct 21, 2026·Beckman Coulter2 products

Sold nationwide. Certain vials of Microgenics MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control (Level 1, Lot OPRO29061A) show inconsistent quality from vial to vial. This variability can cause low recovery of parathyroid hormone (PTH) in lab testing, potentially delaying results that are reported to patients and doctors.

Moderate·FDA·Oct 21, 2026·Microgenics

Sold nationwide. Some Gore VIABIL Short Wire Biliary Endoprosthesis devices (models VSWVH0808 and VSWVN1006) may have been labeled with the wrong length. These are small, flexible tubes placed in bile ducts to keep them open. If a doctor uses a device with incorrect length information, it could affect proper placement.

Moderate·FDA·Oct 21, 2026·Gore

Sold nationwide. In2bones USA distributed CoLag bone screws labeled as fully threaded that are actually partially threaded. This mismatch could affect surgical outcomes if the wrong screw type is used during orthopedic procedures. The error affected 29 units distributed across multiple states.

Moderate·FDA·Oct 21, 2026·In2bones

Sold nationwide. The vented cap on this high-level disinfectant bottle can become blocked, causing gas to build up inside. When the pressure increases, the bottle may swell, and opening it could release vapor or liquid that may expose users to the chemical if protective equipment is not properly worn.

Moderate·FDA·Oct 21, 2026·Steris3 products

Sold nationwide. Ethicon surgical sutures were packaged with an alcohol-based fluid that was not part of the product design. If the fluid contacts the suture during surgery, it can weaken the suture's strength and knot security, potentially causing wound complications including bleeding or reopening.

Moderate·FDA·Oct 21, 2026·Ethicon

Sold nationwide. Baxter Healthcare's Likorall overhead patient lifts may experience motor shaft breakage combined with reduced safety system performance, causing the lift strap to lower faster than expected during use. This malfunction could result in patient injury if a significant fall occurs.

Serious·FDA·Oct 21, 2026·Baxter

Sold nationwide. BioFire Diagnostics is recalling specific lots of three infection test panels: the FilmArray Pneumonia Panel, the FilmArray Pneumonia Panel plus, and the BioFire Joint Infection Panel. The lots may be contaminated, which could cause false positive test results. No injuries have been reported, and 9,949 units are listed as affected.

Moderate·FDA·Oct 21, 2026·BioFire Diagnostics3 products

Sold nationwide. Internal testing found that the sterile pad in the FORWARD Gunshot Wound Kit (Model AFT-GSW) may degrade over time. This degradation could cause small pieces of the pad material to come loose and contaminate the wound during treatment.

Moderate·FDA·Oct 21, 2026·Integrated Medcraft

Sold nationwide. SI-BONE discovered that pelvic fixation screws in certain iFuse TORQ Implant System models failed packaging seal integrity testing. This means sterility cannot be guaranteed for the affected units. No injuries have been reported.

Moderate·FDA·Oct 21, 2026·SI-BONE

Sold nationwide. A firmware issue in certain Ferno-Washington Power F2 Powered Fastening Systems can cause the device to intermittently lose or reduce its powered functionality when used with compatible Power X2 stretchers. Affected devices may stop operating in powered mode or perform at reduced power, which could delay or interrupt patient transport.

Moderate·FDA·Oct 21, 2026·Ferno

Sold nationwide. Sarnova HC assembled some Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipacks (10-pack, Item 670272-KIT, Lot ASM0043314) with pediatric nasal cannulas instead of adult nasal cannulas. This size mismatch could result in incorrect gas sampling or fit during use. About 2,500 kits were distributed across the Midwest and Mountain regions.

Moderate·FDA·Oct 21, 2026·Sarnova

Sold nationwide. Boston Scientific discovered that 403 units of the NaviFlex LW Pusher Advx Panc. Stent were incorrectly manufactured with an extra guidewire exit port that should not be present on this device model. This manufacturing error could affect how the device performs during use.

Moderate·FDA·Oct 21, 2026·Boston Scientific

Sold nationwide. 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

Sold nationwide. 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

Sold nationwide. 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, 2026·Becton Dickinson2 products

Sold nationwide. 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, 2026·Medtronic2 products

Sold nationwide. 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

Sold nationwide. 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, 2026·Instrumentation Laboratory2 products

Sold nationwide. 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 Herbs

Sold nationwide. Walker Foods, Inc. recalled Marca El Pato Salsa para Enchiladas (28 oz cans) because the product contains salt, garlic, and onions that are not listed on the label. People with allergies or sensitivities to these ingredients could be at risk if they rely on the label to make safe choices.

Moderate·FDA·Oct 21, 2026·El Pato

Sold nationwide. Holsum Spinach Flour Tortillas (large, 8-count packages) contain FD&C Blue No. 1 and FD&C Yellow No. 5 food dyes that are not listed on the label. People with sensitivities or allergies to these dyes may be affected. The affected product was distributed in Puerto Rico and the US Virgin Islands.

Moderate·FDA·Oct 21, 2026·Holsum

Sold nationwide. 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·Paragon 28

Sold nationwide. 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

Sold nationwide. 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

Sold nationwide. 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·Zydus

Sold nationwide. 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·Teva

Sold nationwide. Ventec Life Systems is recalling 12 ventilator models used for ventilatory support, including VOCSN+Pro, VC+Pro, VOCSN, VCSN+Pro, V+Pro, VC, V+ Pro Emergency and V*Home, some in Japan versions. The internal flow transducer cable connector may disconnect from the internal board, which could cause the system to reboot and interrupt ventilation therapy. The notice reports no injuries, and the devices were distributed nationwide, including Puerto Rico.

Serious·FDA·Oct 20, 2026·Ventec Life Systems12 products

Sold nationwide. Cronus Pharma is recalling one lot of AnaSed Equine Injection (xylazine 100 mg/mL), a sedative for horses, due to reports of product discoloration. The affected lot is C25110AV1 with an expiration date of November 2027. Discoloration may indicate a quality issue with the medication.

Moderate·FDA·Oct 20, 2026·AnaSed