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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 3 of 1581

Evidence Product Join Root cause
device-recall:cfres:198615 TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S Official recall number · Z-1248-2023 Under Investigation by firm
device-recall:cfres:198325 CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment. Official recall number · Z-1225-2023 Device Design
device-recall:cfres:195615 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. Official recall number · Z-1767-2022 Package design/selection
device-recall:cfres:195663 AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US Official recall number · Z-1769-2022 Under Investigation by firm
device-recall:cfres:195989 Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 Official recall number · Z-1779-2022 Process control
device-recall:cfres:196009 Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies. Official recall number · Z-0082-2023 Error in labeling
device-recall:cfres:196092 N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299 Official recall number · Z-0094-2023 Under Investigation by firm
device-recall:cfres:196087 N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297 Official recall number · Z-0093-2023 Under Investigation by firm
device-recall:cfres:195555 ZAP-X Radiosurgery System Official recall number · Z-1742-2022 Software design
device-recall:cfres:195730 PTS Panels CHOL+GLU Test Strips (REF 1765) Official recall number · Z-1741-2022 Labeling Change Control
device-recall:cfres:195920 FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510 Official recall number · Z-1747-2022 Component change control
device-recall:cfres:196119 cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings. Official recall number · Z-0097-2023 Under Investigation by firm
device-recall:cfres:196046 Medicina Oral Tip Syringe 0.5ml Code: OT005 Official recall number · Z-0109-2023 Nonconforming Material/Component
device-recall:cfres:196117 EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. Official recall number · Z-0126-2023 Process control
device-recall:cfres:196101 ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. Official recall number · Z-0102-2023 Under Investigation by firm
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:196068 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure. Official recall number · Z-0128-2023 Under Investigation by firm