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Philips released a software update (version 4.5.0) for the Patient Information Center iX that changes how mobile event notifications are filtered. The system makes these changes without alerting users, so staff may not realize their notification settings have been altered.

Moderate·FDA·Jan 28, 2026

Edan Diagnostics is recalling 16 EDAN medical monitoring products after receiving an FDA letter about possible cybersecurity issues. The products include fetal and maternal monitors, vital signs monitors, patient monitors, a central monitoring system, and a telemetry transmitter. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·Edan Diagnostics16 products

Community Products is recalling three Rifton Equipment models, the TRAM (K310), Low Base TRAM (K320), and E-Pacer (K660), because the body support strap may fray. The recall covers about 4,800 units and was distributed in the US and several other countries. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·Community Products3 products

Sysmex America's TS-10/TS-10H Tube Sorter may experience an unexpected loss of electromagnetic holding force in the lift mechanism under certain conditions. This could cause the lift to move downward unintentionally. The issue affects 44 specific units identified by serial number.

Moderate·FDA·Jan 28, 2026·Sysmex

Beckman Coulter's LDL Cholesterol OSR6x96 reagent may give inaccurate test results when patients have high triglyceride levels (above 1500 mg/dL). The test can overestimate LDL cholesterol by up to 29% in some samples, which could affect patient care decisions.

Moderate·FDA·Jan 28, 2026

Intuitive Surgical has recalled certain Ion Vision Probe Bags (model 490127) because the sterile pouch seal may be compromised or incomplete. These bags are used to store the Vision Probe during lung biopsy procedures. A compromised seal could allow contamination of the sterile device.

Moderate·FDA·Jan 28, 2026

MicroPort Orthopedics distributed a hip implant trial component (HIPTURN FEM HEAD TRIAL 36MM) in the United States without FDA premarket authorization. The company sent approximately 91 units to distributors across multiple states. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·MicroPort Orthopedics

Tyber Medical is recalling two sizes of left distal radius plates from its VOLT Wrist Treatment System, 164 units in total. The supplier made the plates with threads facing the wrong direction. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·Tyber Medical2 products

Two Leaseir MHR Xcell surgical lasers used for hair removal and skin treatment were distributed with console labels missing the required "DANGER" symbol. The missing warning label could prevent users from recognizing laser hazard warnings. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·Leaseir Technologies

Merit Medical is recalling seven inflation devices and kits, including Allwell and Merit Medical products. The inflation device handle may detach from the syringe during a procedure. No injuries have been reported.

Moderate·FDA·Jan 28, 20267 products

ICU Medical is recalling three Plum infusion pump models: the Plum Duo Infusion Pump, Plum Duo Precision IV Pump, and Plum Solo Precision IV Pump. In certain cases, the pump's automatic flush feature for piggyback therapy can show a limit violation message that prevents the flush from being programmed. No injuries have been reported.

Moderate·FDA·Jan 28, 20263 products

Philips has identified two software issues in Azurion R3.1 systems that may cause the device to restart continuously, lose X-ray imaging capability, lose motorized movement, display incorrect images, or lose data. One issue affects all models; a second affects only systems with a Poly-G3 frontal stand.

Moderate·FDA·Jan 28, 2026

Certain GE Healthcare Omni Legend PET scanners may occasionally produce streaking artifacts in scan images. This visual distortion appears as lines in the images displayed on the scanner console and could affect image quality used for clinical diagnosis.

Moderate·FDA·Jan 28, 2026

RaySearch Laboratories is recalling nine RayStation and RayPlan radiation therapy treatment planning software entries. Certain regions of interest with no contours, which have a material override or are of type Bolus, Fixation, or Support, may not invalidate calculated radiation dose as intended when their geometry is changed or their material override is removed. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·Raysearch Laboratories9 products

Lily's Bakery Factory Cuban Crackers (8 oz, UPC 5700300060, expiration 05/01/2026) contain food dyes—FD&C yellow #5, FD&C yellow #6, and FD&C red 40—that are not listed on the package label. These dyes can trigger allergic reactions in people with sensitivity to artificial food colorings. The product was distributed only in Florida.

Moderate·FDA·Jan 28, 2026

Bakkavor's Meal Simple Red Lentil Dal Soup (16 oz containers, lot 882428, best by 1/11/2026) may contain milk that is not listed on the label. Some containers may have the wrong product inside. This poses a risk to people with milk allergies or sensitivities.

Moderate·FDA·Jan 28, 2026

Catao Market is recalling four Gaceniga Authentic Cuban Loaf Cake products, in Classic and Raisins varieties and in full (24 oz) and mini (12 oz) sizes. The labels do not declare FD&C Yellow #5, a color additive that some people are sensitive to. The products were distributed only in Florida, and no injuries have been reported.

Moderate·FDA·Jan 28, 20264 products

Gold Star Distribution Inc. distributed multiple food products from a facility where rodents and rodent activity were found. The recall affects snack foods, candy, beverages, baby food, and many other items sold in Indiana, Minnesota, and North Dakota.

Moderate·FDA·Jan 28, 2026

Southern Rocklobster LTD USA is recalling frozen Australian Greenlip Abalone (9 pieces, 23.5 oz) due to potential Listeria monocytogenes contamination. The affected product has lot number 5996 with a best-before date of November 29, 2027. The contaminated abalone was distributed to customers at multiple locations in California.

Moderate·FDA·Jan 28, 2026

Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules because some bottles may contain capsules that have lost potency (strength) due to leakage and oxidation. This means the medication may not work as intended. The recall affects specific lot numbers expiring in February and April 2027.

Moderate·FDA·Jan 28, 2026

Specialty Process Labs is recalling one lot of Thyroid, USP (an active pharmaceutical ingredient used in manufacturing) because it does not meet strength standards. The affected lot may contain less active ingredient than labeled, which could affect the potency of products made with it.

Moderate·FDA·Jan 28, 2026·Specialty Process Labs

Rising Pharmaceuticals is recalling Furosemide Tablets, USP 40 mg (a water pill used to treat swelling and high blood pressure) because some bottles may contain a foreign substance. The affected lot is FUB125042G with an expiration date of May 2027. This recall affects 4,212 bottles distributed nationwide.

Moderate·FDA·Jan 28, 2026·Graviti Pharmaceuticals

Cipla USA is recalling Diclofenac Sodium Topical Gel 1% (batch XHBG, expiring 08/31/2027) because it failed to meet required pH specifications during quality testing. The gel may not work as intended or could cause skin irritation. No injuries have been reported so far.

Moderate·FDA·Jan 28, 2026

Academy Sports + Outdoors is recalling Magellan Odyssey Rocker Chairs sold between September and October 2025 because the chair legs can break. This poses a risk of falls and injury. The chairs have a metal frame with mesh backrest and were sold in charcoal, navy, olive green, and teal colors.

Moderate·CPSC·Jan 22, 2026

Angry Orange Enzyme Stain Remover products may contain Pseudomonas aeruginosa bacteria, which can cause serious infections in people with weakened immune systems, lung conditions, or external medical devices. The bacteria can enter the body through inhalation, eyes, or breaks in the skin. People with healthy immune systems are typically not at risk.

Moderate·CPSC·Jan 22, 2026·Thrasio

ICU Medical is recalling two products, the Pulsator Arterial Blood Sampling Kit and the Portex Spinal Tray, with 64,290 affected units each. Some syringes may have a crack on the syringe collar, which can cause delayed or repeated blood draws or fluid delivery, and blood leakage during arterial sampling or fluid delivery. No injuries have been reported.

Moderate·FDA·Jan 21, 20262 products

Medtronic has recalled certain Abre Venous Self-Expanding Stents due to a manufacturing issue with the stent material (Nitinol) that can cause the stent to be smaller than intended when deployed. This reduced size may result in the stent moving out of position after placement.

Moderate·FDA·Jan 21, 2026

Intuitive Surgical is recalling certain da Vinci SP Access Port Kits because the sterile trays may develop cracks during storage or handling. A cracked tray could allow bacteria or other contaminants to enter, compromising the sterile field during surgery. No injuries have been reported.

Moderate·FDA·Jan 21, 2026

Instrumentation Laboratory has recalled a coagulation test reagent (Part Number 0020006800, Lot N1136730) used to evaluate blood clotting and monitor heparin therapy due to potential microbial contamination. The affected lot expires 12/31/2025 and was distributed worldwide including multiple U.S. states and countries. No injuries have been reported to date.

Moderate·FDA·Jan 21, 2026

Hologic's ThinPrep CytoLyt Solution (a buffered cell wash used in laboratory testing) from lot number 5062EC has been found to contain fungal contamination. The affected product was distributed nationwide. No injuries have been reported.

Moderate·FDA·Jan 21, 2026