Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOG...
Incomplete seals on sterile product
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Med...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-30...
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.
Diowave Laser System, REF: Diowave 250W
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.
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART ...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258...
Potential for mislabeled syringe produced by the i.v.STATION device.
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Numbe...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SF...
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 BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOG...
Incomplete seals on sterile product
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UD...
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).
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. A...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWork...
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIO...
Incomplete seals on sterile product
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
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, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
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.
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
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.