Connecticut recalls

A faulty component supplied by a vendor — a 16F dual-valved splittable sheath introducer — was included in certain Arrow International hemodialysis catheter kits. The sheath may fail to split as designed during insertion, potentially causing procedural delays, pain, bleeding, bruising, or tissue damage.

Arrow International is recalling specific lots of Arrow-Clark VectorFlow hemodialysis catheters because they contain a faulty sheath introducer component from a supplier. The introducer may fail to split properly during insertion, which could cause difficulty withdrawing the device, prolonged procedure time, pain, and potential bleeding or tissue injury.

Arrow International included a defective 16F dual-valved splittable sheath introducer in certain hemodialysis catheterization kits. The sheath introducer may not split properly during removal, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, and tissue or vessel wall injury.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the server. No injuries have been reported.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the system. This affects 10 units distributed nationwide.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the system. This affects 11 units worldwide.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through the Edison Health Link subscription service. The vulnerability could potentially allow unauthorized access to the system. No patient harm has been reported.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution CT, Revolution Apex, and Revolution Ascend CT scanners deployed through Edison Health Link (EHL). The vulnerability could potentially allow unauthorized access to the system. This affects 38 units worldwide.

Medline has identified particulate (small particles) in the fluid path of Namic Manifolds within certain TAVI medical convenience kits. The kits were distributed nationwide and internationally. No injuries have been reported.

Medline has identified particles inside the fluid pathways of Namic Manifolds used in cardiac catheterization kits. These kits are used during heart procedures. The contamination could potentially affect the performance of the devices during medical procedures.

Medline has identified particles in the fluid pathway of certain cardiac catheterization manifold kits used in heart procedures. The affected kits span multiple product lines and lot numbers manufactured between 2024 and 2025. No injuries have been reported.

Medline identified particles inside the fluid pathways of Namic Manifolds used in three medical convenience kits: Angiography Cath Lab, Cath Lab Pack, and Angio Kit. These particles could potentially affect the performance of the manifold during use. Approximately 508 kits have been distributed across the U.S. and several other countries.

Medline has identified particulate matter inside the fluid pathway of certain Namic Preceptor Manifold blood pressure transducers. This contamination could affect the accuracy of blood pressure readings or damage the device during use. No injuries have been reported to date.

Medline has identified particles inside the fluid path of certain Namic Preceptor Manifold blood pressure transducers. These particles could interfere with accurate blood pressure readings or damage the device during use.

Medline identified small particles present inside the fluid pathways of certain Namic Angiographic Manifolds used in cardiac bypass procedures. These manifolds are medical devices that control and direct fluid flow during heart surgery. The contamination was discovered in 1,975 units across multiple lot numbers.

Medline has identified particles in the fluid pathway of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. These manifolds are used to manage fluid flow during heart and lung bypass surgery. The contamination could potentially affect the safety and performance of the device during use.

Medline Industries identified particulate matter in the fluid path of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. The contamination could potentially affect the safety and performance of these critical medical devices during use.

Some DJO IceMan CLASSIC3 cold therapy units (model 11-9099, lot 110525) have a broken connector that may temporarily interrupt cold therapy during treatment. No injuries have been reported. The issue affects about 96 units distributed across the US and Canada.

Some DJO DONJOY IceMan CLASSIC3 cold therapy units (model 11-1424) have a broken connector that can interrupt cold therapy temporarily. This affects prescribed rehabilitation treatments. No injuries have been reported.

Some DJO DONJOY ICEMAN CLASSIC3 cold therapy units (model 11-1422) may have a broken connector that could temporarily stop the cold therapy from working as prescribed. The connector failure affects specific production lots and has been identified in devices distributed across the U.S. and Canada. No injuries have been reported.

Some DONJOY ICEMAN CLASSIC CUBE cold therapy units (model 11-0494) contain a broken connector that may temporarily interrupt cold therapy during treatment. This affects units from specific lot codes distributed across the U.S. and Canada. No injuries have been reported.

On-X Life Technologies released and distributed 10 mitral heart valves (Model ONXMC-25/33) before completing all required quality and performance testing. Because testing was incomplete, the company cannot confirm the valves meet all safety and performance specifications. The affected valves were distributed internationally to South Korea.

Windstone Medical Packaging's Custom Convenience Kit (Angio Pack, part numbers AMS6908E and AMS6908F) contains Medline Namic angiographic syringes with a defect: the rotating adapter can unwind during use, causing the syringe to loosen or fully disconnect from the manifold. This disconnection could expose patients to biohazard contamination, blood loss, infection, or air embolism.

Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn contains soy lecithin that is not listed on the label. The product was distributed in Connecticut and New York. People with soy allergies or sensitivities who eat this popcorn could have a serious allergic reaction.

Swad Mango Flavored Masala Candy contains Blue 1 food dye that is not listed on the label. Blue 1 is an FDA-approved color additive, but it must be clearly declared on the package. People with sensitivity or allergy to this dye would not know it is present.

Swad Orange Flavored Masala Candy contains undeclared FD&C Yellow 6, a food colorant. People with allergies or sensitivities to this dye could have a reaction if they consume the product without knowing it's present.

Dakota Honey Company's Honey Flight spreadable spun honey in four flavors may contain stainless steel dust, flakes, or plastic shreds. The contamination was discovered in products produced between December 19, 2025 and April 3, 2026 and sold in Florida, Georgia, South Dakota, and online nationwide. No injuries have been reported.

Dakota Honey Company Spreadable Spun Honey in Jalapeno flavor may contain stainless steel dust, flakes, or shreds of plastic. The contamination was discovered in jars produced at the Winner, South Dakota facility and sold between December 2025 and April 2026.

Dakota Honey Company's Spreadable Spun Honey in cinnamon-infused flavor may contain stainless steel dust, flakes, or shreds of plastic. The contamination was discovered during production at their Winner, South Dakota facility. No injuries have been reported.

Dakota Honey Company's Spreadable Spun Honey may contain stainless steel dust, flakes, or shreds of plastic. The contamination was discovered during production. Affected products were sold at retail locations in Florida, Georgia, and South Dakota, as well as nationwide through internet sales.