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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 9 of 1581

Evidence Product Join Root cause
device-recall:cfres:185485 Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. Official recall number · Z-1141-2021 Process control
device-recall:cfres:185951 SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use. Official recall number · Z-1275-2021 Other
device-recall:cfres:185850 PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC Official recall number · Z-1257-2021 Process control
device-recall:cfres:185682 Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator). Official recall number · Z-1190-2021 Device Design
device-recall:cfres:184600 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures Official recall number · Z-1260-2021 Component design/selection
device-recall:cfres:186019 In-View Clear Leggings Bulk Non-Sterile Official recall number · Z-1302-2021 Nonconforming Material/Component
device-recall:cfres:185885 Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset. Official recall number · Z-1312-2021 Process design
device-recall:cfres:185176 B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract. Official recall number · Z-0965-2021 Under Investigation by firm
device-recall:cfres:185430 ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K Official recall number · Z-1081-2021 Process change control
device-recall:cfres:185877 Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems Official recall number · Z-1330-2021 Software Design Change
device-recall:cfres:185960 BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. Official recall number · Z-1335-2021 Process change control
device-recall:cfres:186026 The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint. Official recall number · Z-1316-2021 Packaging change control
device-recall:cfres:185195 SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Official recall number · Z-0984-2021 Under Investigation by firm
device-recall:cfres:185252 INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. Official recall number · Z-1018-2021 Under Investigation by firm
device-recall:cfres:184844 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU Official recall number · Z-0946-2021 Under Investigation by firm
device-recall:cfres:185188 KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. Official recall number · Z-0977-2021 Under Investigation by firm
device-recall:cfres:185180 PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct. Official recall number · Z-0969-2021 Under Investigation by firm
device-recall:cfres:185300 NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. Official recall number · Z-1062-2021 Under Investigation by firm
device-recall:cfres:185242 INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. Official recall number · Z-1009-2021 Under Investigation by firm
device-recall:cfres:185301 PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Official recall number · Z-1063-2021 Under Investigation by firm
device-recall:cfres:185305 MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter. Official recall number · Z-1067-2021 Under Investigation by firm
device-recall:cfres:185428 CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K Official recall number · Z-1079-2021 Process change control
device-recall:cfres:185258 INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. Official recall number · Z-1024-2021 Under Investigation by firm
device-recall:cfres:185276 NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Official recall number · Z-1042-2021 Under Investigation by firm
device-recall:cfres:185251 INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. Official recall number · Z-1017-2021 Under Investigation by firm