Medical device recalls

Siemens is recalling four ACUSON ultrasound imaging systems: ACUSON Orgin, ACUSON Orgin ICE, ACUSON Sequoia and ACUSON Sequoia Select. A software issue may cause the Color Doppler setting to activate unintentionally. That setting has not received FDA clearance, and the activation could cause the system to crash or become unresponsive. The recall was distributed in the US states of CA, CT, KY, NC and TX and in Germany, Italy and India.

Moderate·FDA·Nov 6, 2026·Siemens4 products

TransMedics is recalling three OCS Liver System products: Liver Perfusion Sets (model 3200), Liver Solution Infusion Sets (model 3457), and Solution Delivery Cassettes (model 1467). The cassettes were assembled with syringes made with an atypical lubricant, which may cause sub-par performance and has the potential to cause leaks. The recall covers 1,179 perfusion sets, 90 infusion sets and 55 cassettes, distributed nationwide in Nebraska and to Italy, and no injuries have been reported.

Moderate·FDA·Nov 6, 2026·TransMedics3 products

Medtronic Xomed recalled two ear ventilation tube products, the Sheehy Ventilation Tube 5PK Button 1.27 FLPL and the Bobbin Ventilation Tube 5PK 1.14 FLPL, because the tubes were not subjected to the required sterilization process. After implantation, this could cause infection and inflammation, potentially leading to temporary hearing impairment, ear fluid discharge, and the need for antibiotics. The notice reports no injuries.

Moderate·FDA·Nov 6, 2026·Medtronic Xomed2 products

TransMedics recalled three OCS products: the OCS Heart Perfusion Set (Model 1200), the OCS Liver Perfusion Set (Model 3200), and the OCS Heart Instrumentation Tool Set (Model 1401). The FDA says the device kits were incorrectly assembled and include incorrect components. The recall was distributed nationwide in the US (NE, AZ, CA, FL, GA, IL, MA, MI, MN, NC, NJ, OH, TX, UT, WA) and in Australia, France, Italy and Taiwan. No injuries have been reported.

Moderate·FDA·Nov 6, 2026·TransMedics3 products

This recall covers 46 TransMedics OCS Liver Perfusion Sets (model 3200), which were incorrectly assembled and contain incorrect accessories. The sets were distributed in 12 states, and no injuries have been reported.

Moderate·FDA·Nov 6, 2026·TransMedics

TransMedics is recalling three OCS organ perfusion sets used for organ transport: the OCS Heart Perfusion Set (Model 1200, software rev 3), the OCS Liver Perfusion Set (Model 3200, software rev 3), and the OCS Lung Mission Critical Plus Perfusion Set (Model 2200, software rev 1). The perfusion module in these sets may have an unprogrammed Front End Board, which can stop the system from getting past startup and cause it to show the error "Unsupported Perfusion Module Present." The notice says the product was distributed worldwide, including nationwide in the US in several states and in Serbia, and reports no injuries.

Moderate·FDA·Nov 6, 2026·TransMedics3 products

Vesco Medical is recalling 7 Vesco Q products: the Vesco Q Enteral Feeding Pump (model VED-701) and six Vesco Q feed sets (models VED-050, VED-051, VED-052, VED-053, VED-054 and VED-059). The pump may deliver enteral fluids outside its labeled accuracy of plus or minus 5%, so feeds may be over- or under-delivered compared with the prescribed dose. The agency says this could cause temporary or medically reversible effects, with a remote chance of serious harm. No injuries have been reported.

Moderate·FDA·Nov 6, 2026·Vesco Medical7 products

Four Siemens ARTIS imaging systems are in this recall: ARTIS icono biplane, ARTIS icono ceiling, ARTIS icono floor and ARTIS pheno. The systems may not carry out movement control commands as intended, and may show the message "Limited stand/table movement, SC." The affected units are in California, Kentucky, New York and Texas, and no injuries have been reported.

Moderate·FDA·Nov 6, 2026·Siemens4 products

Some TCD radiofrequency electrodes may have small cut marks on the Tyvek side of the sterile pouch. If the sterile barrier is compromised and the devices are used, microbial or other foreign material could enter patient tissue, which may lead to infection, pain, inflammation, allergic reaction, or the need for more medical or surgical treatment. No injuries have been reported.

Moderate·FDA·Nov 6, 2026·Boston Scientific

Philips Medical Systems Nederland B.V. is recalling Allura Xper systems running software releases R8.1.x or R8.2.x that are configured with a FlexVision monitor. The software issue may cause the FlexVision software application to become unresponsive during clinical use.

Moderate·FDA·Nov 6, 2026·Philips

Zynex Medical M-Wave muscle stimulators may deliver constant electrical impulses to all four electrodes at once, instead of alternating between them as designed. This may cause muscle fatigue. The recall covers model 701200 with firmware 4.3 and was distributed nationwide. No injuries have been reported.

Moderate·FDA·Nov 6, 2026·Altivera Medical

Siemens is recalling two Atellica CH reagents: Atellica CH HDL Cholesterol (HDLC) and Atellica CH Total Protein_2 (TP_2). Reagent probe carryover on the Atellica CH and Atellica CI analyzers may cause falsely elevated Hemoglobin A1c results and falsely depressed Direct Bilirubin 2 results, which may affect patient samples, quality control, and calibrator results. No injuries have been reported, and the products were distributed in the US and many other countries.

Moderate·FDA·Nov 6, 2026·Siemens2 products

Medtronic is recalling 3 related products used to program and check Medtronic cardiac implantable devices: the CareLink SmartSync Device Manager App (M01A02), the Programmer 24970A, and the RF Head 24967 Patient Connector and RF Head 24967 EUR MKT. Bluetooth disconnections may occur between the device manager software and its accessories, and during a SmartSync patient session this may lead to undesirable or incomplete parameter programming that could cause harm. No injuries have been reported.

Moderate·FDA·Nov 6, 2026·Medtronic3 products

W L Gore & Associates is recalling certain GORE VIABAHN Endoprosthesis devices with Heparin or PROPATEN Bioactive Surface. The devices were made on equipment that was not operating with valid parameters, which may cause the distal tip to separate. The notice reports no injuries.

Moderate·FDA·Nov 6, 2026·Gore

Luminex updated the Instructions for Use for the LIAISON PLEX Gram-Negative Blood Culture Assay to say that repeat testing is recommended whenever a positive family-level-only result is obtained. FDA says the issue may contribute to incorrect or delayed diagnosis of bloodstream infection. No injuries have been reported.

Moderate·FDA·Nov 5, 2026·Luminex

The shelf label on a Halyard Arthroscopy Pack was printed as "Extremity" instead of "Arthroscopy Pack." The recall covers 17 kits, and the notice reports no injuries.

Moderate·FDA·Nov 5, 2026·AVID Medical

Intelerad has identified a cybersecurity vulnerability in IntelePACS software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or lock legitimate users out. A separate software issue may cause unintended deletion of image data from an external archive integration.

Moderate·FDA·Nov 4, 2026·Intelerad

GE HealthCare found a nonconformance in certain Senographe Pristina VIA systems. In 3D+2D manual mode, when the anode track and filter combination is configured differently, the collimator blades might show in the image or the collimator might open more than expected, and the wrong collimator filter might be used for the selected anode track. This could deliver a minor additional X-ray dose to the patient and cause obvious image artifacts.

Moderate·FDA·Nov 4, 2026·GE3 products

Corin Medical is recalling 22 Unity Knee ASC Modular Handles, part number 1232040, which are included in the Corin Unity ASC Instrument System. The locking mechanism may fail, so instruments already attached may not disengage and the handle may not fit securely onto unattached instruments. No injuries have been reported.

Moderate·FDA·Nov 3, 2026·Corin Medical

Remel, Inc. is recalling one lot of Yeastone Broth used in antibiotic susceptibility testing of mycological clinical specimens. The affected lot did not meet specifications and may report false susceptibility to Azole-family antifungal agents. No injuries have been reported.

Moderate·FDA·Nov 3, 2026·Remel

Baxter is recalling five surgical table and operating table column models: TruSystem 7500, TruSystem 7000 U, TS7500 MOBIUS, and TruSystem 7500 Hybrid Plus. The main lift may unexpectedly drop to its lowest position during use, and the tabletop could not be raised again after a drop. This has been linked to unexpected wear of the main lift assembly, also called the telescopic spindle. An uncontrolled drop may cause abrupt patient displacement, which could lead to traumatic injury, airway compromise, or surgical complications. Baxter has received three complaints and no patient injuries have been reported.

Serious·FDA·Nov 3, 2026·Baxter5 products

Cochlear Limited is recalling four Nucleus Nexa cochlear implants with Contour Advance electrodes (model CI1000) distributed in New Jersey, New York and Pennsylvania. A manufacturing deviation caused incomplete electrode welds, resulting in one or more open circuits. No injuries have been reported.

Moderate·FDA·Nov 3, 2026·Cochlear

restor3d Inc. recalled certain Veritas Reverse Total Shoulder Replacement implants, sizes 1 and 2 with the 40 mm polymer liner. The FDA says this pairing may leave some polyethylene components without adequate retention strength, potentially causing dislocation, reduced range of motion, or revision surgery. No injuries have been reported.

Moderate·FDA·Nov 3, 2026·Restor3d

The recall covers 118 Shimadzu Trinias Opera Smart, Opera Grand and Smart OBL interventional fluoroscopic X-ray systems with C-arm support. The mounting bolts securing the C-arm drive unit may not be torqued to specification, potentially compromising structural stability and safe operation. No injuries have been reported.

Moderate·FDA·Nov 3, 2026·Shimadzu

Henry Schein is recalling 13 Perma Sharp surgical suture products, sold under Henry Schein and HSI item numbers, because the products lack 510(k) clearance from FDA. The recall covers U.S. nationwide distribution and shipments to Canada, Uganda, and the Cayman Islands. No injuries have been reported.

Moderate·FDA·Nov 3, 2026·Henry Schein13 products

Baxter is recalling two products: the TruSystem 7000 U Operating Table (dV), product code 1723633, and the mobile column TruSystem 7500 U, product code 1730720. The main lift may unexpectedly drop to its lowest position during use, and the tabletop may not be able to be raised again, which could cause abrupt patient displacement during surgery. The notice lists possible serious outcomes including traumatic injury and airway compromise. The products were distributed nationwide, with confirmed distribution in IL, MO and TX.

Serious·FDA·Nov 3, 2026·Baxter2 products

AVID Medical, Inc. is recalling Halyard MINOR PACK kits, model VASF105-08, because the header bags may have open seals, which could compromise sterility. The notice covers 108 kits. No injuries have been reported.

Moderate·FDA·Nov 3, 2026·AVID Medical

Edwards Lifesciences is recalling 164 Commander M Delivery Systems, model 9880CM29A, from four lots. A manufacturing issue may cause the cardiovascular balloon to rupture. The notice reports no injuries.

Serious·FDA·Nov 2, 2026·Edwards Lifesciences

FDA classified this as a Class I recall of 11 Cardinal Health Presource PBDS kits, distributed in the US and Canada. Each kit contains BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100, and the infusion sets were recalled for performance issues. The kits are labeled with names such as anesthesia, cath lab, C-section, labor, and emergency kits. No injuries have been reported.

Serious·FDA·Nov 2, 2026·Cardinal Health11 products

Artivion recalled one CryoPatch SynerGraft pulmonary human cardiac patch (Model SGP010) because it came from a 64-year-old donor, which is older than the program's accepted range of newborn to 60 years. The patch was already implanted, and because long-term data on these patches are limited, early graft dysfunction cannot be ruled out. No injuries have been reported.

Moderate·FDA·Oct 30, 2026·Artivion