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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, 20262 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

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

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, 202641 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

The adjustable tilt arm that holds certain Lithonia Lighting RSX outdoor luminaires to poles or wall brackets can break, causing the fixture to fall. The company has received reports of arm failures and four instances of fixtures falling, though no injuries have been reported so far.

Moderate·CPSC·Oct 22, 2026

BYD Coach & Bus is recalling about 15 certain 2023-2024 Ride Type A school buses. An electrical contactor may fail, so the controls may not be able to stop the wheelchair lift, which can keep moving while occupied and raises the risk of injury. No injuries have been reported.

Moderate·NHTSA·Oct 22, 2026·BYD Coach & Bus

Chrysler (FCA US, LLC) is recalling about 13,330 certain 2026 Dodge Durango vehicles. Damaged terminals in the tail light wiring harness can cause the tail lights to fail, which makes the vehicle harder for other drivers to see. The vehicles do not meet Federal Motor Vehicle Safety Standard 108 for lamps.

Moderate·NHTSA·Oct 22, 2026

Chrysler is recalling certain MOPAR tail lights, part numbers 68272126AC and 68272127AC, because terminals in the wiring harness may be damaged. This can cause the tail lights to fail, reducing visibility to other drivers and increasing the risk of a crash. The recall covers 2,921 units, and no injuries have been reported.

Moderate·NHTSA·Oct 22, 2026

Nissan is recalling about 392 spare tire accessory kits (part number T99MB7SF0A) sold for certain 2026 Sentra vehicles. The tire placard lists the wrong spare tire size and inflation pressure, so these vehicles do not meet federal tire selection safety requirements. Incorrect inflation could increase the risk of a crash.

Moderate·NHTSA·Oct 22, 2026

Wedgewood Pharmacy is recalling certain compounded veterinary medications shipped between February and October 2026 because lab testing data was unreliable, meaning some products may be weaker or stronger than intended. The affected medications include powders, pastes, oral liquids, injectables, and topical products for companion, equine, exotic, zoo, and aquatic animals. Wedgewood discovered the issue through its own quality checks and has received 98 complaints, including 7 serious ones.

Moderate·FDA·Oct 21, 2026·Wedgewood Pharmacy

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, 20262 products

Certain Greiner VACUETTE blood collection tubes (lot B26043FM) may be contaminated with EDTA, a chemical that can interfere with test results. This contamination can cause lab tests to show falsely high potassium and falsely low calcium levels, which could lead to serious medical decisions based on incorrect results.

Moderate·FDA·Oct 21, 2026

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

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

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

The implantable clip in Merit Medical's Scout MD Delivery System may not deploy properly during surgery. This could prevent the reflector from working as intended to guide the surgical procedure.

Moderate·FDA·Oct 21, 2026

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

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, 20266 products

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, 202612 products

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, 20264 products

The female Luer lock adapter on certain Cook Williams Cystoscopic Injection Needles may not be properly attached due to a manufacturing error. This defect could cause the procedure to take longer or not work as intended.

Moderate·FDA·Oct 21, 2026

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

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, 20262 products

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

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

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