Skip to content
Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 17 of 1581

Evidence Product Join Root cause
device-recall:cfres:188892 DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118 Official recall number · Z-2602-2021 Under Investigation by firm
device-recall:cfres:188983 Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Official recall number · Z-2599-2021 Under Investigation by firm
device-recall:cfres:188895 uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. Official recall number · Z-2593-2021 Device Design
device-recall:cfres:189073 AMX Navigate Mobile X-Ray System Official recall number · Z-2590-2021 Process control
device-recall:cfres:188989 DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) Official recall number · Z-2614-2021 Environmental control
device-recall:cfres:188936 ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024 Official recall number · Z-2550-2021 Under Investigation by firm
device-recall:cfres:188868 VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged Official recall number · Z-2485-2021 Process control
device-recall:cfres:188273 The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t Official recall number · Z-2543-2021 Under Investigation by firm
device-recall:cfres:188829 Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device Official recall number · Z-2527-2021 Packaging change control
device-recall:cfres:188926 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212 Official recall number · Z-2544-2021 Under Investigation by firm
device-recall:cfres:188845 Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device Official recall number · Z-2539-2021 Packaging change control
device-recall:cfres:188835 Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device Official recall number · Z-2533-2021 Packaging change control
device-recall:cfres:188934 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216 Official recall number · Z-2548-2021 Under Investigation by firm
device-recall:cfres:188841 Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device Official recall number · Z-2537-2021 Packaging change control
device-recall:cfres:188946 Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120 Official recall number · Z-2560-2021 Under Investigation by firm
device-recall:cfres:188621 Bone Marrow Transplantation biopsy needle Official recall number · Z-2489-2021 Other
device-recall:cfres:188848 Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device Official recall number · Z-2540-2021 Packaging change control
device-recall:cfres:187860 NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 Official recall number · Z-1978-2021 Material/Component Contamination
device-recall:cfres:187818 A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting Official recall number · Z-1958-2021 Device Design
device-recall:cfres:187964 HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. Official recall number · Z-2072-2021 Nonconforming Material/Component
device-recall:cfres:187798 Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs. Official recall number · Z-1972-2021 Device Design
device-recall:cfres:187076 ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 Official recall number · Z-1937-2021 Environmental control
device-recall:cfres:187515 Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA Official recall number · Z-1907-2021 No Marketing Application
device-recall:cfres:187197 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Official recall number · Z-1742-2021 Vendor change control
device-recall:cfres:187138 ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures. Official recall number · Z-1702-2021 Vendor change control