Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
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.
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS...
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 401923; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ...
Due to nonconforming products being inadvertently distributed.
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.
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-V...
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.
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.
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
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.
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.
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-...
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
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
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
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.
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,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 401575; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOG...
Incomplete seals on sterile product
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOG...
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.
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIO...
Incomplete seals on sterile product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Numbe...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.