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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 60 of 1581

Evidence Product Join Root cause
device-recall:cfres:173661 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use Official recall number · Z-2705-2019 Component design/selection
device-recall:cfres:173544 SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovascular use Official recall number · Z-2645-2019 Component design/selection
device-recall:cfres:172080 SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use Official recall number · Z-2588-2019 Component design/selection
device-recall:cfres:173663 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070", REF SA6MAC40. for cardiovascular use Official recall number · Z-2707-2019 Component design/selection
device-recall:cfres:173508 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use Official recall number · Z-2624-2019 Component design/selection
device-recall:cfres:172092 SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use Official recall number · Z-2599-2019 Component design/selection
device-recall:cfres:175692 Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker. Official recall number · Z-2492-2019 Other
device-recall:cfres:175352 Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011, REF 5-22111, REF 5-22211 g) 6.0 mm, REF 5-22212, REF 5-22312, REF 5-22112 h) 6.5 mm, REF 5-22313, REF 5-22213, REF 5-22013, REF 5-22113 i) 7.0 mm, REF 5-22214, REF 5-22314, REF 5-22014, REF 5-22114 j) 7.5 mm, REF 5-22215, REF 5-22315 k) 8.0 mm, REF 5-22216, REF 5-22316 l) 8.5 mm, REF 5-22217 m) 9.0 mm, REF 5-22218 Product Usage: Tracheal tube/airway management Official recall number · Z-2314-2019 Process control
device-recall:cfres:175855 Vanguard XP Tibial Tray 83 mm Item # 195253 Official recall number · Z-2536-2019 Manufacturing material removal
device-recall:cfres:175358 Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management Official recall number · Z-2316-2019 Process control
device-recall:cfres:175850 Vanguard XP Tibial Tray 69 mm Item # 195248 Official recall number · Z-2531-2019 Manufacturing material removal
device-recall:cfres:175828 XP-CR Tibial Tray - Interlok 75mm Item # 195275 Official recall number · Z-2510-2019 Manufacturing material removal
device-recall:cfres:167380 VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia Official recall number · Z-0392-2019 Under Investigation by firm
device-recall:cfres:167425 Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments. Official recall number · Z-0094-2019 Employee error
device-recall:cfres:167185 Colpo-Pneumo Occluder, Part CPO-6 Official recall number · Z-0098-2019 Other
device-recall:cfres:166940 Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System. Official recall number · Z-0103-2019 Device Design
device-recall:cfres:167019 Bronchofiberscope BF-XP40 Official recall number · Z-3306-2018 Other
device-recall:cfres:167204 VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) Official recall number · Z-3258-2018 Component design/selection
device-recall:cfres:166767 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper. Official recall number · Z-3272-2018 Nonconforming Material/Component
device-recall:cfres:167012 Bronchofiberscope BF-P40 Official recall number · Z-3299-2018 Other
device-recall:cfres:167011 Bronchovideoscope BF-P240 Official recall number · Z-3298-2018 Other
device-recall:cfres:167487 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing, Official recall number · Z-0361-2019 Under Investigation by firm
device-recall:cfres:168663 Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. Official recall number · Z-0311-2019 Software design
device-recall:cfres:167925 Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Official recall number · Z-0327-2019 Under Investigation by firm
device-recall:cfres:167336 BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter. BD Nexiva device is designed to protect the clinician from accidental needle stick injuries and minimize exposure to blood during the insertion process. The needle shield is designed to not release from the catheter adapter until the needle tip is protected and cannot be rearmed once activated. The BD Nexiva device is intended for use in the peripheral vascular system to provide access for the administration of fluids, medication, blood and blood products, and for the withdrawal of blood samples. This catheter may be used for any patient population with consideration given to patient size, appropriateness for solutions being infused and duration of therapy. Official recall number · Z-0384-2019 Under Investigation by firm

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