Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom...
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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. M...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
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 CLASSIC CUBE Model/Catalog Number: 11-...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
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.
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, ...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOG...
Incomplete seals on sterile product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
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
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, Product Number 401575; 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.
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc...
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.
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).
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom...
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.
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, ...
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococ...
Product has the potential for false positive results
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.