Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
🏥 Medical Devices Class I - Dangerous
Incomplete seals on sterile product
All Recalls
95,018 total recalls in our database
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
🏥 Medical Devices Class I - Dangerous
Incomplete seals on sterile product
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Windstone Medical Packaging
🏥 Medical Devices Class I - Dangerous
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.
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
On-X Life Technologies
🏥 Medical Devices Class I - Dangerous
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
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.
🏥 Medical Devices Class I - Dangerous
Due to nonconforming products being inadvertently distributed.
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Product has the potential for false positive results
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 flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
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.
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
🏥 Medical Devices Class I - Dangerous
Incomplete seals on sterile product
🏥 Medical Devices Class I - Dangerous
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 flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
🏥 Medical Devices Class I - Dangerous
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
🏥 Medical Devices Class I - Dangerous
Incomplete seals on sterile product
🏥 Medical Devices Class I - Dangerous
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.
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
🏥 Medical Devices Class I - Dangerous
Incomplete seals on sterile product
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Aniara Diagnostica
🏥 Medical Devices Class I - Dangerous
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.