The latest headlines across every section, pulled from official and open-access sources.
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time… — Medtronic Neuromodulation · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism. — Windstone Medical Packaging, Inc. · Class I · Ongoing
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. — On-X Life Technologies, Inc. · Class II · Ongoing
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. — GE Medical Systems, LLC · Class II · Ongoing
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. — ARROW INTERNATIONAL, LLC · Class I · Ongoing
Due to nonconforming products being inadvertently distributed. — Stryker Corporation · Class II · Ongoing
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. — ARROW INTERNATIONAL, LLC · Class I · Ongoing
Product has the potential for false positive results — Quidel Corporation · Class II · Ongoing
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flick… — Dexcom, Inc. · Class II · Ongoing
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. — ARROW INTERNATIONAL, LLC · Class I · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flick… — Dexcom, Inc. · Class II · Ongoing
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. — GE Medical Systems, LLC · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. — ARROW INTERNATIONAL, LLC · Class I · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Due to broken connector which may result in a temporary interruption of prescribed cold therapy. — DJO, LLC · Class II · Ongoing
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. — Aniara Diagnostica LLC · Class II · Ongoing