Kentucky recalls

Merit Medical Systems is recalling certain Allwell Angioplasty Packs because the inflation device handle may detach from the syringe during a procedure. This could interrupt treatment and require the procedure to be stopped or repeated. No injuries have been reported.

Merit Medical Systems is recalling certain Custom Procedure Kits because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt the procedure or cause other complications. No injuries have been reported.

Merit Medical Systems is recalling its Custom Manifold Kit (model K09-13203A) because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt treatment or require procedure restart. No injuries have been reported.

Merit Medical Systems is recalling multiple Custom Inflation Kit models because the handle may detach from the syringe during use. This could interrupt a medical procedure. No injuries have been reported so far.

Merit Medical Systems is recalling specific lots of their Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt patient care. No injuries have been reported.

Merit Medical Systems is recalling the Allwell Inflation Device (model IS-30-A) used in angiographic procedures because the handle may detach from the syringe during use. This could compromise the procedure and patient safety. The recall affects specific lot numbers distributed worldwide.

Merit Medical Systems' basixCOMPAK inflation device handle may detach from the syringe during a medical procedure. This affects multiple reference numbers and lots of the 20 mL, 30 atm/bar model used in clinical settings.

Mazor Robotics has recalled its Mazor X robotic guidance system due to software errors in certain versions that could cause incorrect positioning of surgical instruments during spinal surgery. The affected software versions are 5.0.1, 5.1.2, and 5.1.3. About 549 systems worldwide are affected, and no injuries have been reported.

Baxter Healthcare has recalled certain SIGMA Spectrum infusion pumps (model 35700BAX2) because they may contain defective grease on internal gears. This defective grease does not lubricate properly, which can cause premature wear of the pump mechanism and lead to the pump delivering too much medication or allowing medication to flow freely without stopping.

ICU Medical's Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic line flush after piggyback therapy. In certain situations, the pump displays an error message that blocks the flush from being set up, even though the flush is a normal part of the treatment process.

ICU Medical's Plum Duo Precision IV Pump may prevent clinicians from programming an automatic flush after piggyback therapy in certain situations. When this happens, the pump displays an error message and the flush cannot be set up, which could affect how medications are delivered.

ICU Medical Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic flush after piggyback therapy. When attempting to set up this flush feature, the pump may display an error message that blocks the programming, even though the flush itself is a safe feature.

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.

ICU Medical's Tego Connector needle-free access devices have a silicone seal that may bulge, separate, or tear. This defect can cause fluid leaks, blockages, inability to draw or inject medication, and potential exposure to contamination or air in the bloodstream during hemodialysis or IV therapy.

RayStation versions 17.0.0 and 17.0.1 have a software error that prevents dose calculations from updating properly when certain regions of interest are modified. This can occur when regions have no contours but include material overrides or are marked as Bolus, Fixation, or Support types. Users may not see updated radiation doses after making changes.

RayStation version 2024B has a software issue where calculated radiation doses may not update correctly when certain regions of interest (ROIs) are modified. This affects ROIs without contours that have material overrides or are classified as Bolus, Fixation, or Support types. Clinics using this version should verify their dose calculations are accurate.

RayStation radiation therapy planning software versions 2024A SP1 and 2024A SP2 have a bug that prevents dose calculations from updating correctly when certain regions of interest (ROIs) are modified. This affects ROIs without contours that have material overrides or are classified as Bolus, Fixation, or Support types. If changes are made to these ROIs, the system may not recalculate doses as intended.

RaySearch's RayStation radiation therapy planning software version 10B SP1 has a flaw where calculated radiation doses may not update correctly when certain regions of interest are modified. This affects regions with no contours that have material overrides or are classified as Bolus, Fixation, or Support types. Clinical staff may unknowingly rely on outdated dose calculations.

RayStation radiation therapy treatment planning software (versions 14.0.0, 15.0.0, and 15.1.3) may not properly update calculated radiation doses when certain regions of interest are modified. This can occur when regions have no contours but have material overrides or are classified as bolus, fixation, or support types. Changes to these regions may not trigger the dose recalculation as intended.

RayStation versions 12A, 12A SP1, and 12A SP2 contain a software bug that prevents dose calculations from updating properly when certain regions are edited. This affects only specific region types (Bolus, Fixation, Support) with no contours that have material overrides. Users may not see updated radiation doses after making changes.

RaySearch RayStation/RayPlan radiation therapy planning software (versions 11B through 11B SPT1) has a bug that prevents dose calculations from updating correctly when changes are made to certain regions of interest with material overrides or specific geometry types. This could result in treatment plans using outdated radiation dose calculations.

RaySearch Laboratories identified a software bug in RayStation/RayPlan versions 11.0.0 through 11.0.4 (11A, 11A SP1, SP2, SP3) used for radiation therapy treatment planning. When certain regions of interest have no contours but have material overrides or are classified as Bolus, Fixation, or Support types, the software fails to recalculate radiation doses correctly if you modify or remove the material override. This could result in outdated or incorrect dose calculations being used for treatment planning.

RaySearch Laboratories' RayStation/RayPlan version 10B has a software issue that can prevent proper recalculation of radiation therapy doses when certain regions are modified. This affects specific treatment planning scenarios where regions have no contours but have material overrides or are classified as Bolus, Fixation, or Support types. Stale dose calculations may be used instead of updated ones.

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.

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.

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.

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.

Mikario Trading's 5-in-1 convertible baby gyms can obstruct an infant's breathing because the floor mat violates safety standards for infant cushions. The pink gyms, sold on TikTok Shop, convert from an activity center to a tummy-time mat and include a toy bar and plush toys. About 500 units were sold between May and October 2025.

Iristar Minoxidil Spray Bottles sold on Amazon contain minoxidil but lack child-resistant packaging required by law. A young child who swallows the contents could suffer serious injury or death. No injuries have been reported so far.

Cumbor retractable safety gates sold online have a gap between the gate and floor that allows a child's torso to fit through, creating a serious risk of entrapment and injury. About 4,520 units were sold online starting in September 2025. No injuries have been reported yet.