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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 54 of 1581

Evidence Product Join Root cause
device-recall:cfres:203364 F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) Official recall number · Z-2656-2023 Software design
device-recall:cfres:203292 EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359 Official recall number · Z-2655-2023 Software design
device-recall:cfres:202829 Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable Official recall number · Z-2664-2023 Under Investigation by firm
device-recall:cfres:203262 2008T HD SYS. CDX W/BIBAG BLUESTAR Official recall number · Z-0033-2024 Device Design
device-recall:cfres:203206 Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 Official recall number · Z-0027-2024 Device Design
device-recall:cfres:202577 Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter Official recall number · Z-0015-2024 Employee error
device-recall:cfres:202938 Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461) Official recall number · Z-0008-2024 Under Investigation by firm
device-recall:cfres:202634 Citrine QTRAP Mass Spectrometer, Part Number 5063685 Official recall number · Z-0039-2024 Component design/selection
device-recall:cfres:203324 Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 Official recall number · Z-0041-2024 Software Design Change
device-recall:cfres:202820 NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers Official recall number · Z-2573-2023 Under Investigation by firm
device-recall:cfres:203131 Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers Official recall number · Z-2575-2023 Under Investigation by firm
device-recall:cfres:202722 nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers Official recall number · Z-2541-2023 Under Investigation by firm
device-recall:cfres:202424 ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 Official recall number · Z-2582-2023 Software design
device-recall:cfres:202670 HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U Official recall number · Z-2514-2023 Process control
device-recall:cfres:202733 QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers Official recall number · Z-2552-2023 Under Investigation by firm
device-recall:cfres:202720 nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers Official recall number · Z-2539-2023 Under Investigation by firm
device-recall:cfres:203584 Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix Official recall number · Z-0161-2024 Employee error
device-recall:cfres:203417 Robotics Pack, REF SJVO56B Official recall number · Z-0178-2024 Process control
device-recall:cfres:203406 LAVH, REF BBLV21C Official recall number · Z-0172-2024 Process control
device-recall:cfres:203512 ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194 Official recall number · Z-0196-2024 Software design
device-recall:cfres:203162 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System Official recall number · Z-0124-2024 Component design/selection
device-recall:cfres:202778 Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental Official recall number · Z-0154-2024 Process change control
device-recall:cfres:203422 Cath Cardiac Pack, REF IHCC03V Official recall number · Z-0182-2024 Process control
device-recall:cfres:202906 PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE Official recall number · Z-0056-2024 Other
device-recall:cfres:202901 PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips Official recall number · Z-0052-2024 Other

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