Medical device recalls

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

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·Philips

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, 2026·Medtronic4 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·B. Braun

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·Abbott

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·Philips

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·Intellijoint Surgical

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·Steris

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·LeMaitre Vascular

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, 2026·Mindray8 products

Bolts that secure the longitudinal movement mechanism on the Canon Medical Alphenix INFX-8000C/B5 imaging system may loosen over time. This can cause the patient tabletop to shift unexpectedly, leading to misalignment during imaging procedures and motion errors.

Moderate·FDA·Oct 14, 2026·Canon

Certain Polymedco SEDIPLAST blood collection tubes (models S-100 and S-1000) may have a defect that causes increased resistance when a pipette is inserted. This pressure buildup can cause the tube cap to detach or be forcibly ejected, potentially exposing lab workers and work areas to blood.

Moderate·FDA·Oct 14, 2026·Polymedco

AVID Medical is recalling 15 surgical kits and packs, including DaVinci and Shands Jacks products, because they may be contaminated with a lubricant used during manufacturing. The recalled kits were distributed nationwide, with the listed states including AZ, CA, FL, MD, NE, and TX. No injuries have been reported.

Moderate·FDA·Oct 14, 2026·AVID Medical15 products

One personalized pelvic implant was shipped to the wrong customer due to a distribution error. The device is designed specifically for individual patients and should not be used by anyone other than the intended recipient.

Moderate·FDA·Oct 14, 2026·Onkos Surgical2 products

Nihon Kohden's CNS-6200 Series Central Nurse Station has a cybersecurity flaw that could allow someone to disrupt the system. If exploited, the flaw could prevent nurses from seeing patient monitoring data and alarms across multiple beds in a hospital.

Serious·FDA·Oct 14, 2026·Nihon Kohden

Some MiniMed Flex insulin pumps were shipped without completing required quality verification tests. These pumps may have problems including failure to work at startup, moisture damage, slow charging, connection issues with glucose monitors or the app, missed occlusion alerts, weak alarm sounds, or inaccurate insulin delivery.

Serious·FDA·Oct 14, 2026·Medtronic

Medline is recalling two bariatric basic steel rollator walkers, 2,659 units in total. The front wheel assembly can disconnect from the frame, causing the front wheels to become loose or detach during use, which could lead to falls and serious injuries such as head trauma or fractures. No injuries have been reported, and the products were distributed nationwide in the US and to Canada.

Serious·FDA·Oct 14, 2026·Medline2 products

Stryker Sustainability Solutions is recalling a specific lot of BARD EP XT Decapolar Steerable diagnostic catheters (Reference 201007) used in heart rhythm procedures. Some units may have a compromised sterile barrier on the primary pouch packaging, which could allow contamination if the catheter is used. This poses a risk of particle buildup, infection, or blood clots.

Moderate·FDA·Oct 14, 2026·Stryker

Beckman Coulter identified a software issue in its DxC 500i and DxC 500 AU Clinical Chemistry Analyzers used for testing plasma samples. After a user changes a test to non-default units and later activates a configuration change, the analyzer may revert to the default units without warning, which can lead to falsely elevated reported results. The recall covers 2 product groups with 6 modules and analyzers in total.

Moderate·FDA·Oct 14, 2026·Beckman Coulter2 products

DRG International's Sperm Ab ELISA test (model EIA-1826) may return false negative results, meaning it could fail to detect sperm antibodies when they are actually present. This affects lot 320K046 distributed worldwide, including the US and multiple countries in Europe and Asia.

Moderate·FDA·Oct 14, 2026·DRG

Safeguard US compression bandages used in trauma kits and first aid bags may degrade over time, potentially allowing foreign material to enter a wound. This degradation could require additional wound cleaning and may increase the risk of infection or scar tissue formation.

Moderate·FDA·Oct 14, 2026·Safeguard

Limitless Cryo Spa LLC distributed Glypto cryo machines without obtaining required FDA 510(k) clearance. The devices were supplied to facilities nationwide. No injuries have been reported.

Moderate·FDA·Oct 14, 2026·Limitless Cryo Spa

Cardinal Health Presource Packs contain Medtronic Microstream components that may be difficult to disconnect from a patient's breathing tube. Medtronic has updated the instructions for these kits to address this issue. The difficulty could delay treatment or cause unintended removal of the tube, potentially leading to serious breathing complications.

Moderate·FDA·Oct 14, 2026·Cardinal Health

Philips Medical Systems has recalled certain Spectral CT and Spectral CT 7500 RT imaging systems due to software problems. These issues may cause image artifacts, incorrect slice thickness, or unintended movement of the system during operation.

Moderate·FDA·Oct 14, 2026·Philips

HALYARD Laparoscopy Comprehensive Pack II (REF: 49332) was labeled as "latex free" but contained a latex urethral catheter. This mislabeling poses a risk to patients with latex allergies who may use the kit. The recall affects 396 kits with specific lot numbers distributed nationwide.

Moderate·FDA·Oct 14, 2026·GRI Medical & Electronic Technology

QUANTUM OPS ADAPTABLE Beach Chair surgical positioners contain an inadequate weld in the patient head positioning system (BC-0105 subcomponent). This manufacturing defect could potentially affect the stability and safety of the device during surgical procedures. The defect was identified in specific lot numbers distributed in California and Texas.

Moderate·FDA·Oct 14, 2026·Quantum Ops

Steris is recalling six VERIFY biological indicator and challenge pack products used to monitor steam sterilization cycles. The spore population in these products may fall below its minimum shelf-life specification, so an indicator could show no growth even when a steam cycle did not achieve the intended spore reduction. No injuries have been reported.

Moderate·FDA·Oct 14, 2026·Steris6 products

A data-entry error caused one lot of Medical Action Industries' urinary clean-catch collection kits to be labeled with an expiration date of March 31, 2027, when the correct date is February 28, 2027. This means the kits could be used beyond their intended shelf life, potentially affecting test reliability.

FDA·Oct 14, 2026·Medical Action Industries