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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 72 of 1581

Evidence Product Join Root cause
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: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: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: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:188102 Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component. Official recall number · Z-2130-2021 Unknown/Undetermined by firm
device-recall:cfres:188003 Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06 Official recall number · Z-2091-2021 Under Investigation by firm
device-recall:cfres:188092 Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component. Official recall number · Z-2120-2021 Unknown/Undetermined by firm
device-recall:cfres:188104 Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component. Official recall number · Z-2132-2021 Unknown/Undetermined by firm
device-recall:cfres:187477 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980 Official recall number · Z-2103-2021 Mixed-up of materials/components
device-recall:cfres:187862 OxyMask O2 Adult REF OM-1125-14 Official recall number · Z-2141-2021 Nonconforming Material/Component
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: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
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: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:186205 ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit Official recall number · Z-1412-2021 Under Investigation by firm
device-recall:cfres:186793 CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 Official recall number · Z-1635-2021 Vendor change control

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