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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, 202615 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

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, 20262 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

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, 20262 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

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

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, 20266 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

The FDA found that Omni Gold Anti-Marks Cream Extra Brightening, a skin-brightening product made in Pakistan, contains mercury. Mercury is toxic and can cause serious health problems when absorbed through the skin. The contaminated product was distributed nationwide through eBay.

Serious·FDA·Oct 14, 2026·DANALVIG LLC2 products

Apothecary Pharma is recalling two sterile injection vials because the company cannot assure they are sterile. The recall covers 22 vials of Tirzepatide Injection 18 mg/mL (4 mL multi-dose vial) and 1 vial of Apothecary NAD+ Injection 200 mg/mL (6 mL multi-dose vial), distributed nationwide. No injuries have been reported.

Moderate·FDA·Oct 14, 2026·Apothecary Pharma2 products

Sun Pharmaceutical is recalling three tretinoin cream USP 0.05% products, sold in 45 g and 20 g tubes under the Taro and Northstar Rx names. The cream failed the FDA's impurity and degradation standards. No injuries have been reported.

Moderate·FDA·Oct 14, 20263 products

Carolina Infusion, LLC is recalling QUAD-MIX injectable medication (a compounded injection containing papaverine, phentolamine, alprostadil, and tropicamide) due to concerns about sterility. The issue stems from processing equipment used to prepare the product. The affected lot is 08032026@24, with a Beyond Use Date of 09/17/2026.

Moderate·FDA·Oct 14, 2026·Carolina Infusion16 products

A single lot of IMAAVY (nipocalimab-aahu) injection contains particulate matter that should not be present in the medication. This affects 49 vials distributed in Ohio. The contamination was detected before the medication reached patients.

Moderate·FDA·Oct 14, 2026·Johnson & Johnson

Cipla USA is recalling one lot of Fosfomycin Tromethamine Granules for Oral Solution due to failed quality testing for impurities and degradation. The affected lot (5KA0405, expiring 12/31/2026) was distributed nationwide. No injuries have been reported.

Moderate·FDA·Oct 14, 2026

Preferred Pharmaceuticals' Lidocaine Ointment USP 5% (generic Xylocaine) in 50 g jars failed to meet content uniformity specifications, meaning the active ingredient may not be evenly distributed throughout the product. This affects four specific lots with expiration dates of April 30, 2027. No injuries have been reported.

Moderate·FDA·Oct 14, 2026

BioSpectra, Inc. is recalling one lot of Tris/Tromethamine, USP, GMP, API Grade manufactured at its Bangor, Pennsylvania facility. The affected lot failed stability testing specifications required for pharmaceutical-grade active ingredients.

Moderate·FDA·Oct 14, 2026·BioSpectra

K.C. Pharmaceuticals is recalling eight sterile eye drop products sold nationwide because they may not be sterile. The products are sold under the Best Choice, Equaline, Good Sense, LEADER, exchange select and Crocodile Tears names. No injuries have been reported.

Serious·FDA·Oct 14, 20268 products

Centric Compounding of Houston, Texas, is recalling three sterile vitamin products sold as Tri-Immune Boost, Glutathione 200 mg/mL and Multidose Myers Cocktail vials. Test results found bacterial endotoxin levels outside acceptable limits. No injuries have been reported.

Serious·FDA·Oct 14, 2026·Centric Compounding4 products

Siemens has recalled its Atellica CH Revised C-Reactive Protein (RCRP) test kit worldwide due to the potential for falsely elevated results. This diagnostic test is used in clinical laboratories to measure inflammation levels. Laboratories using affected lots may have received inaccurate test results.

Moderate·FDA·Oct 7, 2026

Wright Medical manufactured CHARLOTTE CLAW Screws (REF: 40122716) with missing threads on the screwheads. These screws are designed to work with the CLAW II Polyaxial Compression Plating System for foot surgery. If used, the missing threads could prevent the screw from securing properly to the plate, potentially requiring surgery to be extended or alternative procedures performed.

Moderate·FDA·Oct 7, 2026·Wright Medical

Karl Storz shipped HOPKINS Telescope 30° surgical visualization devices with an incorrect label on the eyepiece inside the packaging. The label error affects a small number of eyepieces (6 units) distributed in Arizona, California, and Missouri.

Moderate·FDA·Oct 7, 2026·Karl Storz