Medical device recalls

Illumina is recalling five diagnostic sequencing instruments and servers: NextSeq 550Dx, MiSeq Dx, NovaSeq 6000Dx, DRAGEN Server for NextSeq 550Dx, and VeriSeq Onsite Server V2. The recall covers about 2,700 units, all sold for in vitro diagnostic (laboratory testing) use. A cybersecurity weakness in how these devices communicate with customer-provided computers, storage, or servers could allow data transmission to be compromised. No injuries have been reported.

Moderate·FDA·Oct 30, 2026·Illumina5 products

Natus Medical is recalling Embletta MPR PG sleep monitors because the device may not correctly format its internal memory. Old study data may remain on the device and be updated with incorrect patient information, or recordings may fail to start or end early. No injuries have been reported.

Moderate·FDA·Oct 30, 2026·Natus Medical

Smith & Nephew recalled seven units of the EVOS 3.5MM Lateral Proximal Tibia Plate, 6 Hole Left, 91MM. The implants were labeled and laser etched as a standard lateral tibia plate, but they are actually a partial articular version. No injuries have been reported.

Moderate·FDA·Oct 30, 2026·Smith & Nephew

Accriva Diagnostics is recalling certain Hemochron Jr. APTT test cuvettes, used to check low-dose heparin levels in blood. The clot-activating reagent inside some cuvettes may be out of position or missing, which can cause error codes or falsely high results. Falsely high results could lead to a lower anticoagulant dose than needed, which could raise the risk of blood clots. No injuries have been reported.

Moderate·FDA·Oct 30, 2026·Accriva Diagnostics

Tandem Diabetes Care found that some Tandem Mobi insulin pumps can give false occlusion alarms when no blockage is present. This can cause the pump to stop insulin delivery until the user acknowledges the alarm and restarts therapy. Repeated interruptions could lead to high blood glucose, and in severe cases may require medical care or hospitalization.

Serious·FDA·Oct 30, 2026·Tandem Diabetes Care

ArjoHuntleigh Polska is recalling about 8,780 Carevo height-adjustable shower trolleys, Model BAC1111-01. The side support panel can open unintentionally if the handles are not fully locked and extra force is applied during patient handling, which could cause a patient to fall and be seriously injured.

Moderate·FDA·Oct 29, 2026·Arjohuntleigh

Stryker Leibinger is recalling Precision Pointer Electromagnetic devices because the pointer tube can crack at a laser-welded joint during use. If that happens, loose parts could fall out while the device is inside a patient. No injuries have been reported.

Moderate·FDA·Oct 29, 2026·Stryker

Boston Scientific is recalling certain Nalu TD2 Therapy Discs and TD2 Patient Kits used with the Nalu Neurostimulation System. A firmware problem can cause the disc to try to restart and then fail, so it stops working. If no backup disc is available, the implanted pulse generator may also stop working, which could leave pain signals unblocked. No injuries have been reported.

Moderate·FDA·Oct 29, 2026·Boston Scientific

Pentax Medical is recalling five products: four PENTAX Medical ultrasound endoscope models and the PENTAX Medical OS-H5 water bottle assembly, about 3,140 units in total. The agency's warning labeling was updated to say users must make sure deaerated sterile water is in the assembly before and during procedures. No injuries have been reported.

Moderate·FDA·Oct 28, 2026·Pentax5 products

Abiomed is recalling 900 Impella heart pump controllers in three products: Automated Impella Controller, Impella Optical Controller, and Impella Connect Optical AIC. The units need hardware, firmware, or software updates found during a review of servicing records. Possible problems include the controller failing to recognize the purge cassette, a sticking push button that can cause loss of console control, start-up failure, and a software defect that can show incorrect negative pressure readings. No injuries have been reported.

Serious·FDA·Oct 28, 2026·Abiomed3 products

Medtronic is recalling three CareLink SmartSync products, including the programmer, RF head patient connector and Device Manager app, because a software problem can cause an inaccurate displayed longevity estimate for implanted pulse generators. No injuries have been reported. The recall covers about 61,000 units distributed worldwide.

Moderate·FDA·Oct 27, 2026·Medtronic3 products

BioMerieux is recalling a limited number of EMAG nucleic acid sample preparation instruments used in clinical labs. After updating to firmware SP4 Patch 2, a random software error (Error 10003, Heater timeout) can cause delayed or no results when analyzing clinical samples. No injuries have been reported.

Moderate·FDA·Oct 27, 2026·bioMérieux

Philips is recalling 9 Azurion imaging system models, including Azurion 3, 5, 7 and S configurations. Some of these PCs may contain solid-state drives (SSDs) that are not specified in the Medical Device File, which could lead to reduced reliability over time, such as loss of imaging, a blank or black display, or trouble storing or accessing images. No injuries have been reported. The recall covers units distributed in the US and many other countries.

Moderate·FDA·Oct 27, 2026·Philips9 products

Canon Medical Systems is recalling 15 Alphenix interventional angiography X-ray systems (model INFX-8000C). A software issue can cause an internal error if F-Store or image acquisition is performed while the clinical analysis function is in use. The systems were distributed to hospitals and facilities in 18 states.

Moderate·FDA·Oct 27, 2026·Canon3 products

Philips North America has recalled Model 712010 devices due to a potential for the device to fail immediately after exposure, which could cause the system to stop working. Approximately 563 units are affected.

Moderate·FDA·Oct 26, 2026·Philips

Certain Ziehm Orthoscan VERSA accessory carts and Versa Mini C-Arm systems have welds that do not meet specifications. This defect could cause the monitor arm mounting structure to separate from the cart during use.

Moderate·FDA·Oct 23, 2026·Ziehm Imaging

Medtronic has recalled certain OmniaSecure Model 3930M ventricular leads (used in heart devices for pacing and defibrillation) due to reports of difficulty achieving proper fixation during implantation. This implantation difficulty could potentially cause tissue trauma during the surgical procedure.

Moderate·FDA·Oct 23, 2026·Medtronic

Some ETHILON Nylon Suture needles have distorted curvature and may break during surgical use. This could cause additional injury to soft tissue or blood vessels, including tearing or bleeding during surgery.

Moderate·FDA·Oct 23, 2026·Ethicon

Halyard ANTERIOR HIP PACK surgical kits (model SOAH31) contain a component that was not properly sterilized before packaging. The component was placed outside the sterile barrier and did not receive the required sterilization treatment. This affects 56 kits distributed in Arizona with lot number 1689215 and expiration date 11/06/2026.

Moderate·FDA·Oct 22, 2026·AVID Medical2 products

Medline is recalling 13 surgical drape and medical convenience kit products because the adhesive can be difficult to remove from patients and may leave residue on the skin. No injuries have been reported. The recall covers US nationwide distribution and several other countries.

Moderate·FDA·Oct 22, 2026·Medline13 products

The radiopaque (X-ray visible) material on the Xact mole marker can detach during use. When this happens, the loose material may create artifacts (unwanted marks or shadows) on mammography images, potentially affecting image quality and interpretation.

Moderate·FDA·Oct 22, 2026·Solstice

Medtronic is recalling two product groups in its InterStim system: InterStim SureScan MRI leads and InterStim percutaneous extensions. The recall covers 2 products in total. The company says the wrong lead or extension may have been selected, and an incompatible one may stop the system from working as intended. This could delay surgery or require surgical replacement of the product. No injuries have been reported.

Moderate·FDA·Oct 22, 2026·Medtronic2 products

A software bug in MiniMed Go version 1.2.1 broke the long-acting insulin dose reminder feature for users who had it enabled in earlier versions. When users updated the app, the reminder stopped working silently—without any alert to the user. This could cause users to miss or delay insulin doses, or accidentally take a double dose if they're unsure whether they already dosed.

Moderate·FDA·Oct 22, 2026·Medtronic

Sixteen restor3d MTP foot implants were distributed without proper sterilization. The implants showed orange sterilization indicators, meaning they were never exposed to the sterilization process required to make them safe for surgery. These implants are used to treat arthritis and other conditions in the big toe joint.

Moderate·FDA·Oct 22, 2026·Restor3d

Boston Scientific is recalling 41 Direxion Torqueable Microcatheter models. The hydrophilic coating on the outer tip may not have been fully cured, and some nitinol sleeves have raised ridges caused by laser-cutting misalignment. No injuries have been reported.

Moderate·FDA·Oct 22, 2026·Boston Scientific41 products

The Ion Torrent Genexus Dx DNA/RNA sequencing system software (version 6.8.2.1 and earlier) contains security vulnerabilities that could potentially be exploited. Life Technologies has identified 16 affected sequencers across multiple U.S. states.

Moderate·FDA·Oct 22, 2026·Life Technologies

Stability testing found that ammonia (NH4+) measurements in specific lots of this quality control material drift over time, making the labeled shelf-life claim unreliable. Labs using affected lots may get delayed or inaccurate results, which could delay diagnosis of dangerously high ammonia levels that need urgent treatment.

Moderate·FDA·Oct 22, 2026·Techno-Path Manufacturing3 products

Certain batches of CooperVision Softmed Breathables Advanced Toric contact lenses have incorrect packaging labels stating they are approved for extended wear. These lenses are designed and FDA-approved for daily wear only, not extended wear. The mislabeling could lead users to wear the lenses longer than intended.

Moderate·FDA·Oct 22, 2026·CooperVision

Medtronic MiniMed CareLink Clinic software version 4.4A has a defect in its Settings Calculator feature. When healthcare providers enter custom insulin values, the calculator ignores them and continues using default values instead. This can result in incorrect insulin dose recommendations being sent to patients' insulin pumps, potentially causing patients to receive too much or too little insulin.

Serious·FDA·Oct 21, 2026·Medtronic

Beckman Coulter has recalled certain SW40 rotors (Reference 331302) used in Optima XE and XPN ultracentrifuges due to a defect that can cause rotors to break during operation. Rotor breakage destroys samples being processed and can expose laboratory workers to biohazardous materials. When used for patient testing, breakage may delay diagnostic results.

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