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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 7 of 1581

Evidence Product Join Root cause
device-recall:cfres:192304 SIGNA Excite 3T. Magnetic Resonance Imaging System Official recall number · Z-0859-2022 Device Design
device-recall:cfres:192375 Revolution CT, Revolution CT ES Official recall number · Z-0816-2022 Radiation Control for Health and Safety Act
device-recall:cfres:192367 Alinity m HBV Application Specification File (US and CE) Official recall number · Z-0883-2022 Under Investigation by firm
device-recall:cfres:192684 Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. Official recall number · Z-0877-2022 Component change control
device-recall:cfres:192031 MODEL: X-RAY TV SYSTEM SONIALVISION G4 Official recall number · Z-0868-2022 Software design
device-recall:cfres:192226 Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 Official recall number · Z-0838-2022 Other
device-recall:cfres:190590 BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use Official recall number · Z-0845-2022 Labeling Change Control
device-recall:cfres:192281 Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Official recall number · Z-0832-2022 Employee error
device-recall:cfres:192469 RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29 Official recall number · Z-0849-2022 Device Design
device-recall:cfres:192098 cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 Official recall number · Z-0828-2022 Nonconforming Material/Component
device-recall:cfres:192331 Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Official recall number · Z-0930-2022 Device Design
device-recall:cfres:192384 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument Official recall number · Z-0913-2022 Nonconforming Material/Component
device-recall:cfres:192208 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package. Official recall number · Z-0948-2022 Mixed-up of materials/components
device-recall:cfres:192329 Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Official recall number · Z-0928-2022 Device Design
device-recall:cfres:192565 CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US Official recall number · Z-0936-2022 Device Design
device-recall:cfres:191975 HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8 Official recall number · Z-0960-2022 Under Investigation by firm
device-recall:cfres:192430 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System. Official recall number · Z-0927-2022 Under Investigation by firm
device-recall:cfres:192703 Artis Q zeego, Model Number 10848283 Official recall number · Z-0977-2022 Device Design
device-recall:cfres:192130 Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control. Official recall number · Z-0984-2022 Under Investigation by firm
device-recall:cfres:192460 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 Official recall number · Z-0959-2022 Device Design
device-recall:cfres:192441 Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site Official recall number · Z-0950-2022 Process control
device-recall:cfres:192699 Artis zeego, Model Number 10280959 Official recall number · Z-0973-2022 Device Design
device-recall:cfres:192641 Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q Official recall number · Z-0990-2022 Component design/selection
device-recall:cfres:192648 ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025 Official recall number · Z-0981-2022 Nonconforming Material/Component
device-recall:cfres:192791 Inactivated macrolide-resistant Mycoplasma genitalium Official recall number · Z-0955-2022 Process control

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