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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

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

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

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, 20263 products

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

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

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

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

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

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

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

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