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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 67 of 1581

Evidence Product Join Root cause
device-recall:cfres:195809 Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023 Official recall number · Z-0039-2023 Process control
device-recall:cfres:195755 Hobbs Posi-Stop Injection Needle Catalog Number: 4704 Official recall number · Z-0021-2023 Process control
device-recall:cfres:195770 Hobbs Helical Retrieval Basket Catalog Number: 4830 Official recall number · Z-0032-2023 Process control
device-recall:cfres:195742 Hobbs Medical Cytology Brush Catalog Number: 4206 Official recall number · Z-0014-2023 Process control
device-recall:cfres:196036 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 Official recall number · Z-0002-2023 Software design
device-recall:cfres:195853 Freeman Pancreatic Flexi-Stent Catalog Number: 6566 Official recall number · Z-0061-2023 Process control
device-recall:cfres:195857 Freeman Pancreatic Flexi-Stent Catalog Number: 6584 Official recall number · Z-0065-2023 Process control
device-recall:cfres:195889 CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA1810SB/A, CORCA1810SB/B, CORCA1815B/A, CORCA1815B/B, CORCA1815SB/A, CORCA1815SB/B, CORCA1820B/A, CORCA1820B/B, CORCA1820SB/A, CORCA1820SB/B, CORCA1825B/A, CORCA1825SB/B, CORCA2010B/A, CORCA2010B/B, CORCA2010SB/A, CORCA2010SB/B, CORCA2015B/A, CORCA2015B/B, CORCA2015SB/A, CORCA2015SB/B, CORCA2020B/A, CORCA2020B/B Official recall number · Z-0137-2023 Process change control
device-recall:cfres:196175 Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP Official recall number · Z-0146-2023 Packaging
device-recall:cfres:196311 Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4 Official recall number · Z-0140-2023 Device Design
device-recall:cfres:196397 EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. Official recall number · Z-0151-2023 Under Investigation by firm
device-recall:cfres:196096 BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader. Official recall number · Z-0172-2023 Under Investigation by firm
device-recall:cfres:196257 CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures. Official recall number · Z-0167-2023 Under Investigation by firm
device-recall:cfres:196501 EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. Official recall number · Z-0152-2023 Under Investigation by firm
device-recall:cfres:196361 BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr) Official recall number · Z-0174-2023 Storage
device-recall:cfres:196042 Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures. Official recall number · Z-0177-2023 Other
device-recall:cfres:196277 Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A Official recall number · Z-0192-2023 Pending
device-recall:cfres:196626 X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 Official recall number · Z-0222-2023 Process control
device-recall:cfres:196295 CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST Official recall number · Z-0217-2023 Under Investigation by firm
device-recall:cfres:196587 NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 Official recall number · Z-0223-2023 Under Investigation by firm
device-recall:cfres:196289 CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST Official recall number · Z-0212-2023 Under Investigation by firm
device-recall:cfres:196484 TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F.. Official recall number · Z-0228-2023 Process design
device-recall:cfres:196431 ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. UPN (1)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400 Official recall number · Z-0226-2023 Under Investigation by firm
device-recall:cfres:195433 therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 Official recall number · Z-1651-2022 Under Investigation by firm
device-recall:cfres:195360 Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye. Official recall number · Z-1673-2022 Software design

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