Michigan recalls

Sold nationwide. Radiometer Medical's ABL90 FLEX and ABL90 FLEX PLUS blood analyzers may produce inaccurate test results due to issues with how certain sample types and test parameters are configured. The company has identified that whole blood samples are no longer suitable for two specific tests (FHbF and ctBil), and reportable ranges for some other measurements need adjustment.

Moderate·FDA·Oct 21, 2026·Radiometer Medical

Sold nationwide. Medline Industries recalled a foot-ankle convenience kit (SKU DYNJ65395A) because one component in the kit has an incorrect or discrepant shelf-life label. The issue affects 30 kits distributed in New York. No injuries have been reported.

Moderate·FDA·Oct 21, 2026·Medline

Sold nationwide. Healthmark Industries' vinyl instrument guards have labeling that does not comply with federal requirements under 21 CFR 801. The manufacturer has also updated instructions for steam sterilization of these guards. The recall affects multiple model numbers across various sizes and colors.

Moderate·FDA·Oct 21, 2026·Healthmark Industries

Sold nationwide. IntelePACS, a medical imaging system used in hospitals and clinics, has a software issue where displayed images may not match the printed reports when using certain web browsers. This could lead to confusion during diagnosis or patient care if a clinician relies on mismatched information.

Moderate·FDA·Oct 21, 2026·Intelerad

Sold nationwide. Medline is recalling six convenience kits that contain CONMED AirSeal Access Ports, with 3,551 kits affected for each product listed. The ports may give false overpressure alerts and vent during use, which could delay or end a procedure. The kits were distributed nationwide, including AZ, CA, IN, MD, MO, NJ, OH, and WI, and no injuries have been reported.

Moderate·FDA·Oct 21, 2026·Medline6 products

Sold nationwide. Medline is recalling 12 groups of surgical convenience kits, including cardiac, vascular, spinal, neuro, and ear kits. Some kits contain cannula components that do not meet ISO 80369-7 size requirements, which may cause leaking or breaking during use. No injuries have been reported.

Moderate·FDA·Oct 21, 2026·Medline12 products

Sold nationwide. Howmedica Osteonics is recalling four Triathlon surgical instrument trays, about 2,100 trays in total. The reprocessing instructions call for a 30-minute dry time after sterilizing trays in blue wrap, which may leave a small amount of moisture on the trays. No injuries have been reported.

Moderate·FDA·Oct 21, 2026·Howmedica Osteonics4 products

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