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Sophysa's Pressio 2 ICP Monitoring System (Model PSO-4000) may unexpectedly reboot during use. This device is used in hospitals to measure pressure inside the skull. The reboots could interrupt critical monitoring of patients.

Moderate·FDA·Jan 14, 2026·Sophysa

A software issue in certain BD Pyxis ES Enterprise Server systems may prevent timely updates of patient, medication, and related information from reaching the dispensing cabinets. This could delay access to critical data in healthcare settings. BD and the FDA are working to address the problem.

Moderate·FDA·Jan 14, 2026

Certain Beckman Coulter UniCel DxL 600 analyzers may fail to restart properly after shutdown due to a communication issue. When this happens, the analyzer cannot process patient samples or quality control checks, which can delay test results.

Moderate·FDA·Jan 14, 20262 products

Meridian Bioscience's Revogene C. difficile diagnostic test (a lab assay used with the Revogene instrument) may show declining accuracy over time in certain lots. This could produce false-negative results, meaning the test might not detect C. difficile infection when it is present.

Moderate·FDA·Jan 14, 2026·Meridian Bioscience

Applied Medical Resources has recalled certain Kii Low Profile trocar units because the blade obturator may extend beyond its proper length after assembly. This defect could affect the device's safe function during use. No injuries have been reported.

Moderate·FDA·Jan 14, 2026·Applied Medical Resources

Roche Diagnostics has recalled certain lots of the Elecsys Anti-TSHR blood test due to inconsistent results across different laboratory instruments and variations between calibrator batches. These issues could lead to incorrect or delayed thyroid diagnosis and treatment.

Moderate·FDA·Jan 14, 2026·Roche Diagnostics

Philips Healthcare has recalled certain Incisive CT scanners due to an unstable internal connection in the floating sensor. This instability may cause the scanner to produce incomplete or compromised scans. The issue affects 35 devices distributed across the U.S. and its territories, and no injuries have been reported.

Moderate·FDA·Jan 14, 2026

Siemens LUMINOS Lotus Max and Luminos dRF Max X-ray systems with software version VF11 may show incorrect collimation (beam positioning) when quickly switching between organ programs. This affects only systems with a bucky wall stand for mobile detectors and no ceiling stand.

Moderate·FDA·Jan 14, 2026

Vision RT identified that instructions for the AlignRT InBore radiation therapy system omitted required information about its six Class 1 lasers and their specifications. The missing details are required by federal laser safety regulations. No injuries have been reported.

Moderate·FDA·Jan 14, 2026·Vision RT

AvKARE is recalling Rosuvastatin 10 mg tablets (Lot #49124, expiring 12/31/2026) because they don't dissolve properly in the body. This means the medication may not work as intended. No injuries have been reported so far.

Moderate·FDA·Jan 14, 2026·AvKARE

SpecGx LLC is recalling certain bottles of oxycodone and acetaminophen 10mg/325mg tablets because some tablets may be missing the imprint (marking). This could make it difficult to identify the medication. No injuries have been reported.

Moderate·FDA·Jan 14, 2026·SpecGx2 products

Imprimis is recalling three prefilled eye injection products because they may contain glass-like particles. The products are Dexamethasone Moxifloxacin, Dexamethasone Moxifloxacin Ketorolac, and Tri-Moxi+, with 1,688 affected boxes shipped nationwide. No injuries have been reported.

Moderate·FDA·Jan 14, 2026·Imprimis3 products

Alembic Pharmaceuticals is recalling one lot of Fesoterodine Fumarate 8 mg extended-release tablets because testing found levels of a chemical impurity (diester impurity) that exceed safety limits. The affected lot is 2405003360, which expires January 31, 2026.

Moderate·FDA·Jan 14, 2026

Beaver-Visitec International's BVI Leos Laser and Endoscopy System (Model OME6000U) has a manufacturing defect in the USB cable that connects the Nurse Monitor touchscreen to the System Controller. The cable is missing required ferrite components that protect against electromagnetic interference. Five units with specific serial numbers were affected and distributed in Florida, Michigan, Oklahoma, Texas, and Wisconsin.

Moderate·FDA·Jan 7, 2026·Beaver-Visitec

Philips EPIQ Ultrasound Systems with the X5-1c transducer and certain software versions may unexpectedly restart on their own. This automatic reboot can damage the transducer. No injuries have been reported.

Moderate·FDA·Jan 7, 2026

Sheathes3D Seamless Viral Barrier ultrasound probe covers may have manufacturing defects that could allow contamination during medical use. This poses a risk of infection to patients. The recall affects a limited quantity distributed in Washington State.

Moderate·FDA·Jan 7, 2026·Sheathing Technologies

Ferndale Laboratories is recalling Mastisol Liquid Adhesive (lot 24161B, expiration 10-31-2029) because the butyrate tube can crack when you try to use it, making the product unusable. This affects 24,589 vials distributed in the US and UK.

Moderate·FDA·Jan 7, 2026·Ferndale

Some units of the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe (catalog VS0135.25, lot 2509040) may not fit smoothly through a 25-gauge cannula as intended. This could affect proper use during medical procedures. The recall affects 221 units distributed in the US and Japan.

Moderate·FDA·Jan 7, 2026·Vortex Surgical

Atomstack material processing laser products lack a required remote interlock connector that is designed to shut down the laser if the protective enclosure is opened. This safety feature is mandated by federal laser safety regulations to prevent accidental exposure.

Moderate·FDA·Jan 7, 2026·Atomstack

Glenmark Pharmaceuticals discovered that blister packs containing Ondansetron 4mg orally disintegrating tablets are not fully sealed, allowing tablets to fall out. The affected product was repackaged and distributed nationwide. This applies to lot #19251311 with an expiration date of April 2027.

Moderate·FDA·Jan 7, 2026

Novo Nordisk discovered hair in some prefilled Wegovy injection pens. This affects specific lot numbers manufactured in Denmark. No injuries have been reported.

Moderate·FDA·Jan 7, 2026·Novo Nordisk2 products

CareFusion 213, LLC is recalling BD ChloraPrep Triple Swabsticks (a skin antiseptic swab) because the manufacturer cannot confirm the product was properly sterilized. The affected lot (#5086623, expiring 3/31/2028) was distributed nationwide. No injuries have been reported.

Moderate·FDA·Jan 7, 2026

Beckman Coulter Bicarbonate Reagent (catalog numbers OSR6137, OSR6237, OSR6637) used in laboratory analyzers may produce falsely high bicarbonate test results. This happens because a substance in blood samples called Lactate Dehydrogenase (LDH) interferes with the test. Affected lot numbers are listed in specific ranges for each catalog number.

Moderate·FDA·Dec 31, 2025

A software problem in the Medtronic Restore Clinician Programmer App (versions before v.1.0.4489) can cause a Device Reset message that cannot be cleared. In rare cases, this prevents the pain management device from resuming therapy, causing patients to experience pain symptoms again. The implanted devices themselves are not affected—only the programmer application used by clinicians.

Moderate·FDA·Dec 31, 2025

Cook is recalling three product lines with a total of 7,990 units: Flexor Check-Flo Introducers and Sets, Ring Transjugular Intrahepatic Access Sets, and Rösch-Uchida Transjugular Liver Access Sets. The company found that products in the affected lots may have been made out of specification, with some cut to the wrong length, not properly trimmed, or not inspected correctly. No injuries have been reported.

Moderate·FDA·Dec 31, 20253 products

Diasol is recalling specific lots of its bicarbonate dialysis liquid concentrate because the safety and efficacy of the product cannot be assured. The affected product was distributed nationwide to dialysis facilities in Missouri, California, Arizona, Texas, Illinois, and Massachusetts. No injuries have been reported.

Moderate·FDA·Dec 31, 2025·Diasol6 products

Microbiologics is recalling three lab control products containing Campylobacter jejuni, a bacteria used to test laboratory methods. Some units may fail to grow the target bacteria, which could give inaccurate test results. No injuries have been reported.

Moderate·FDA·Dec 31, 2025·Microbiologics3 products

Zimmer Biomet is recalling 17 catalog numbers of its Affixus Antegrade Femoral Nails. The implant shaft may be undersized along its length, which could lead to a fatigue fracture. No injuries have been reported.

Moderate·FDA·Dec 31, 202517 products

ICU Medical's LifeShield Infusion Safety Software v2.2 has a software issue that limits concentration settings to one decimal place instead of three. This may force users to set drug limits differently than the manufacturer recommends, potentially causing patients to receive too much or too little medication.

Moderate·FDA·Dec 31, 2025

ICU Medical's LifeShield Drug Library Management software version 2.2.1 has a problem where the Change Summary review tool stops working correctly after a library migration. This affects only customers who upgraded from version 2.1x and use Plum Duo v1.1 infusion pumps. When the review tool doesn't work, staff may not catch errors in pump settings.

Moderate·FDA·Dec 31, 2025