Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:209259
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000126;
- Join
- Official recall number ·
Z-2797-2024 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:209436
- Product
- BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
- Join
- Official recall number ·
Z-2737-2024 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:209392
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;
- Join
- Official recall number ·
Z-2919-2024 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:209306
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
- Join
- Official recall number ·
Z-2839-2024 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:209290
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000789;
- Join
- Official recall number ·
Z-2825-2024 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:209415
- Product
- FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
- Join
- Official recall number ·
Z-2941-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:207314
- Product
- CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764, l) 5514418-01166521, m) 5514418-01180241, n) 5514418-01181177, o) 5514418-01183037, p) 5514418-01184556, q) 5514418-01184557, r) 5514418-01185805, s) 5514418-01186277, t) 5514418-01187473, u) 5514418-01188453, v) 5514418-01190677, w) 5514418-01192703, x) 5514418-01192705, y) 5514418-01203242, z) 5514418-01206279, aa) 5514418-01208248, bb) 5514418-01212670, cc) 5514418-01215947, dd) 5514418-01218564, ee) 5514418-01222489, ff) 5514418-01222812, gg) 5514418-01223831, hh) ii) 5514418-01228038, ii) 5514418-01228181, jj) 5514418-01230534, kk) 5514418-01235322, ll) 5514418-01236388, mm) 5514418-01244357, nn) 5514418-01250690, oo) 5514418-01250761, pp) 5514418-01256439; monitor, physiological, patient
- Join
- Official recall number ·
Z-2170-2024 - Root cause
- Software design
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- Evidence
- device-recall:cfres:208994
- Product
- Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- Join
- Official recall number ·
Z-2533-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208933
- Product
- TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
- Join
- Official recall number ·
Z-2507-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:209000
- Product
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
- Join
- Official recall number ·
Z-2513-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208602
- Product
- Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
- Join
- Official recall number ·
Z-2435-2024 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:208348
- Product
- Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
- Join
- Official recall number ·
Z-2431-2024 - Root cause
- Error in labeling
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- Evidence
- device-recall:cfres:207724
- Product
- MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
- Join
- Official recall number ·
Z-2041-2024 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:208887
- Product
- BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
- Join
- Official recall number ·
Z-2500-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208878
- Product
- BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
- Join
- Official recall number ·
Z-2491-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208621
- Product
- BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
- Join
- Official recall number ·
Z-2458-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208875
- Product
- BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
- Join
- Official recall number ·
Z-2488-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208361
- Product
- Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
- Join
- Official recall number ·
Z-2362-2024 - Root cause
- Vendor change control
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- Evidence
- device-recall:cfres:208515
- Product
- UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
- Join
- Official recall number ·
Z-2372-2024 - Root cause
- Employee error
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- Evidence
- device-recall:cfres:208418
- Product
- Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431
- Join
- Official recall number ·
Z-2383-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208451
- Product
- SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
- Join
- Official recall number ·
Z-2407-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208448
- Product
- Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)
- Join
- Official recall number ·
Z-2354-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208372
- Product
- The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
- Join
- Official recall number ·
Z-2337-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208456
- Product
- Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
- Join
- Official recall number ·
Z-2249-2024 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:208158
- Product
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
- Join
- Official recall number ·
Z-2273-2024 - Root cause
- Component design/selection