Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:191239
- Product
- The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
- Join
- Official recall number ·
Z-0539-2022 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:191125
- Product
- BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
- Join
- Official recall number ·
Z-0666-2022 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:191893
- Product
- REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
- Join
- Official recall number ·
Z-0664-2022 - Root cause
- Labeling mix-ups
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- Evidence
- device-recall:cfres:191126
- Product
- BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
- Join
- Official recall number ·
Z-0667-2022 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:191658
- Product
- The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
- Join
- Official recall number ·
Z-0679-2022 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:191292
- Product
- Gentueri Viral Transport Medium (VTM), Sterile, IVD
- Join
- Official recall number ·
Z-0504-2022 - Root cause
- Environmental control
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- Evidence
- device-recall:cfres:191259
- Product
- Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
- Join
- Official recall number ·
Z-0512-2022 - Root cause
- Packaging change control
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- Evidence
- device-recall:cfres:191467
- Product
- Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
- Join
- Official recall number ·
Z-0510-2022 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:191020
- Product
- SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
- Join
- Official recall number ·
Z-0514-2022 - Root cause
- Process control
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- Evidence
- device-recall:cfres:190620
- Product
- ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
- Join
- Official recall number ·
Z-0547-2022 - Root cause
- Software design
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- Evidence
- device-recall:cfres:190646
- Product
- HARDY DIAGNOSTICS CatScreen, 25dsk/vial
- Join
- Official recall number ·
Z-0554-2022 - Root cause
- Process control
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- Evidence
- device-recall:cfres:191509
- Product
- Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
- Join
- Official recall number ·
Z-0557-2022 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:191288
- Product
- Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
- Join
- Official recall number ·
Z-0551-2022 - Root cause
- Labeling Change Control
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- Evidence
- device-recall:cfres:191587
- Product
- 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
- Join
- Official recall number ·
Z-0563-2022 - Root cause
- Mixed-up of materials/components
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- Evidence
- device-recall:cfres:188163
- Product
- Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
- Join
- Official recall number ·
Z-2177-2021 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:188073
- Product
- HeartWare HVAD Driveline Extension Cable, REF 100
- Join
- Official recall number ·
Z-2192-2021 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:188165
- Product
- 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
- Join
- Official recall number ·
Z-2179-2021 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:188116
- Product
- TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000
- Join
- Official recall number ·
Z-2217-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:188368
- Product
- CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
- Join
- Official recall number ·
Z-2224-2021 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:188075
- Product
- HeartWare HVAD Implant Kit, REF 1104JP
- Join
- Official recall number ·
Z-2194-2021 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:188571
- Product
- cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
- Join
- Official recall number ·
Z-2444-2021 - Root cause
- Software design
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- Evidence
- device-recall:cfres:188657
- Product
- Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
- Join
- Official recall number ·
Z-2435-2021 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:188412
- Product
- FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
- Join
- Official recall number ·
Z-2309-2021 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:188608
- Product
- Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
- Join
- Official recall number ·
Z-2285-2021 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:188355
- Product
- CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
- Join
- Official recall number ·
Z-2324-2021 - Root cause
- Unknown/Undetermined by firm