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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 1520 of 1581

Evidence Product Join Root cause
device-recall:cfres:176019 QuickGraft¿ Model # 430PST Official recall number · Z-2548-2019 Under Investigation by firm
device-recall:cfres:176061 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB). Official recall number · Z-2758-2019 Device Design
device-recall:cfres:176158 Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review Official recall number · Z-2560-2019 Software design
device-recall:cfres:175840 XP-XP Tibial Tray - Interlok 73 mm Item # 195756 Official recall number · Z-2521-2019 Manufacturing material removal
device-recall:cfres:175837 XP-XP Tibial Tray - Interlok 83 mm Item # 195759 Official recall number · Z-2518-2019 Manufacturing material removal
device-recall:cfres:175109 Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX¿ Analyzer. Official recall number · Z-2475-2019 Employee error
device-recall:cfres:175624 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128 Official recall number · Z-2480-2019 Nonconforming Material/Component
device-recall:cfres:175617 cobas c513 Analyzer Official recall number · Z-2478-2019 Device Design
device-recall:cfres:175755 HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities. Official recall number · Z-2483-2019 Software Manufacturing/Software Deployment
device-recall:cfres:175369 CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188 Official recall number · Z-2472-2019 Under Investigation by firm
device-recall:cfres:176219 INFUSA PORT KIT DYNDC1840F Official recall number · Z-0085-2020 Under Investigation by firm
device-recall:cfres:176095 BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes Official recall number · Z-0071-2020 Under Investigation by firm
device-recall:cfres:176284 CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065 Official recall number · Z-0094-2020 Under Investigation by firm
device-recall:cfres:176294 IV KIT - SORBAVIEW IVS3475 Official recall number · Z-0104-2020 Under Investigation by firm
device-recall:cfres:176044 BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes Official recall number · Z-0067-2020 Under Investigation by firm
device-recall:cfres:176194 Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944 Official recall number · Z-0119-2020 Device Design
device-recall:cfres:176254 Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771 Official recall number · Z-0065-2020 Labeling False and Misleading
device-recall:cfres:176098 BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes Official recall number · Z-0074-2020 Under Investigation by firm
device-recall:cfres:173119 EyeBOX Model OCL 02 Official recall number · Z-2398-2019 Labeling design
device-recall:cfres:174843 EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836 Official recall number · Z-2377-2019 Nonconforming Material/Component
device-recall:cfres:175173 Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus. Official recall number · Z-2420-2019 Packaging
device-recall:cfres:175166 Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus. Official recall number · Z-2414-2019 Packaging
device-recall:cfres:174064 Skull Anchor Bolts Official recall number · Z-2408-2019 Employee error
device-recall:cfres:174848 EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867 Official recall number · Z-2381-2019 Nonconforming Material/Component
device-recall:cfres:175101 Kit BD Max MRSA XT; Catalog # 443461 Official recall number · Z-2334-2019 Process control

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