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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 18 of 1581

Evidence Product Join Root cause
device-recall:cfres:187307 ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures. Official recall number · Z-1759-2021 Vendor change control
device-recall:cfres:187309 ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures. Official recall number · Z-1761-2021 Vendor change control
device-recall:cfres:187198 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Official recall number · Z-1743-2021 Vendor change control
device-recall:cfres:187179 ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures. Official recall number · Z-1724-2021 Vendor change control
device-recall:cfres:187097 Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue. Official recall number · Z-1781-2021 Equipment maintenance
device-recall:cfres:187367 Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453 Official recall number · Z-1802-2021 Under Investigation by firm
device-recall:cfres:187385 Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569 Official recall number · Z-1816-2021 Under Investigation by firm
device-recall:cfres:186752 COVID-19 Self-Test Kit *** INNOVA *** 7T Official recall number · Z-1537-2021 No Marketing Application
device-recall:cfres:187824 EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar. Official recall number · Z-2051-2021 Employee error
device-recall:cfres:187953 CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; Official recall number · Z-2042-2021 Device Design
device-recall:cfres:187513 Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 Official recall number · Z-1949-2021 Process control
device-recall:cfres:187100 Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable Official recall number · Z-1901-2021 Process control
device-recall:cfres:187657 Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746 Official recall number · Z-1966-2021 Under Investigation by firm
device-recall:cfres:187555 Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 Official recall number · Z-1921-2021 No Marketing Application
device-recall:cfres:187573 Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Official recall number · Z-1904-2021 Component design/selection
device-recall:cfres:187397 v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. Official recall number · Z-1853-2021 Software Manufacturing/Software Deployment
device-recall:cfres:187483 Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx. Official recall number · Z-1872-2021 Nonconforming Material/Component
device-recall:cfres:187533 Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx. Official recall number · Z-1893-2021 Nonconforming Material/Component
device-recall:cfres:187686 VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VENEL14140 /Venovo 9F 14/140/1200mm OUS; VENEL14160 /Venovo 9F 14/160/1200mm OUS; VENEM14040 /Venovo 9F 14/40/800mm OUS; VENEM14060 /Venovo 9F 14/60/800mm OUS; VENEM14080 /Venovo 9F 14/80/800mm OUS; VENEM14100 /Venovo 9F 14/100/800mm OUS; VENEM14120 /Venovo 9F 14/120/800mm OUS; VENEM14140 /Venovo 9F14/140/800mm OUS; VENEM14160 /Venovo 9F 14/160/800mm OUS; VENUL14040 /Venovo 9F 14/40/1200mm US; VENUL14060 /Venovo 9F 14/60/1200mm US; VENUL14080 /Venovo 9F 14/80/1200mm US; VENUL14100 /Venovo 9F 14/100/1200mm US; VENUL14120 /Venovo 9F 14/120/1200mm US; VENUL14140 /Venovo 9F 14/140/1200mm US; VENUL14160 /Venovo 9F 14/160/1200mm US; VENUM14040 /Venovo 9F 14/40/800mm US; VENUM14060 /Venovo 9F 14/60/800mm US; VENUM14080 /Venovo 9F 14/80/800mm US; VENUM14100 /Venovo 9F 14/100/800mm US; VENUM14120 /Venovo 9F 14/120/800mm US; VENUM14140 /Venovo 9F 14/140/800mm US; VENUM14160 /Venovo 9F 14/160/800mm US; Official recall number · Z-1899-2021 Under Investigation by firm
device-recall:cfres:187599 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT Official recall number · Z-1987-2021 Device Design
device-recall:cfres:188006 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 Official recall number · Z-2006-2021 Device Design
device-recall:cfres:187585 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT Official recall number · Z-1984-2021 Device Design
device-recall:cfres:187840 Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231 Official recall number · Z-1999-2021 Nonconforming Material/Component
device-recall:cfres:187755 Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II Programmable 40mLPump 00810335020242 Official recall number · Z-1996-2021 Error in labeling
device-recall:cfres:187607 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT Official recall number · Z-1989-2021 Device Design