May 20, 2026Medical DevicesFDA
Technological Medical Advancements LLC recalls Diowave Laser System, REF: Diowave 250W
Hazard: Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
May 20, 2026Medical DevicesFDA
Jolife AB recalls LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Mo
Hazard: Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-
Hazard: 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.
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152
Hazard: 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.
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151
Hazard: 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.
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Hazard: 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.
May 20, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Hazard: 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.
May 20, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
Hazard: 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.
May 20, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Hazard: 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.
May 20, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
Hazard: 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.
May 20, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
Hazard: 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.
May 20, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
Hazard: 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.
May 20, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Hazard: 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.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Nu
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYN
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEA
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. M
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, mani
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, mani
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
Medline Industries, LP recalls Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, mani
Hazard: Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medical DevicesFDA
DJO, LLC recalls Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Produc
Hazard: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
May 20, 2026Medical DevicesFDA
DJO, LLC recalls Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc
Hazard: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
May 20, 2026Medical DevicesFDA
DJO, LLC recalls Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Produc
Hazard: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
May 20, 2026Medical DevicesFDA
DJO, LLC recalls Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Desc
Hazard: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
May 20, 2026Medical DevicesFDA
On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Hazard: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
May 20, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S
Hazard: 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.