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:208234
- Product
- HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
- Join
- Official recall number ·
Z-2295-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208205
- Product
- Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
- Join
- Official recall number ·
Z-2314-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208195
- Product
- This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
- Join
- Official recall number ·
Z-2261-2024 - Root cause
- Storage
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- Evidence
- device-recall:cfres:208052
- Product
- CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
- Join
- Official recall number ·
Z-2195-2024 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:208259
- Product
- Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
- Join
- Official recall number ·
Z-2221-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:207612
- Product
- Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
- Join
- Official recall number ·
Z-2236-2024 - Root cause
- Other
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- Evidence
- device-recall:cfres:208064
- Product
- EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
- Join
- Official recall number ·
Z-2198-2024 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:208156
- Product
- The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.
- Join
- Official recall number ·
Z-2213-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:207962
- Product
- NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
- Join
- Official recall number ·
Z-2217-2024 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:208053
- Product
- Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
- Join
- Official recall number ·
Z-2214-2024 - Root cause
- Software Design Change
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- Evidence
- device-recall:cfres:208062
- Product
- EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
- Join
- Official recall number ·
Z-2196-2024 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:204870
- Product
- SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
- Join
- Official recall number ·
Z-0695-2024 - Root cause
- Labeling design
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- Evidence
- device-recall:cfres:205279
- Product
- Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
- Join
- Official recall number ·
Z-0791-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:205288
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
- Join
- Official recall number ·
Z-0800-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:205294
- Product
- Bard¿ Suction Connector with ENFit, REF EN0066000
- Join
- Official recall number ·
Z-0806-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:205276
- Product
- TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
- Join
- Official recall number ·
Z-0814-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:205553
- Product
- CombiDiagnost R90 1.0 (709030)
- Join
- Official recall number ·
Z-1087-2024 - Root cause
- Software design
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- Evidence
- device-recall:cfres:205434
- Product
- Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;
- Join
- Official recall number ·
Z-1144-2024 - Root cause
- Process design
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- Evidence
- device-recall:cfres:205122
- Product
- global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
- Join
- Official recall number ·
Z-1089-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:204832
- Product
- Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
- Join
- Official recall number ·
Z-1051-2024 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:205510
- Product
- BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
- Join
- Official recall number ·
Z-1015-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:205319
- Product
- Sperm separation media are used to separate motile sperm from other constituents of semen.
- Join
- Official recall number ·
Z-0998-2024 - Root cause
- Mixed-up of materials/components
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- Evidence
- device-recall:cfres:205508
- Product
- BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
- Join
- Official recall number ·
Z-1013-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:205583
- Product
- Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
- Join
- Official recall number ·
Z-1069-2024 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:205574
- Product
- Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
- Join
- Official recall number ·
Z-0985-2024 - Root cause
- Labeling Change Control