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:209692
- Product
- Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
- Join
- Official recall number ·
Z-3148-2024 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:209693
- Product
- Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
- Join
- Official recall number ·
Z-3149-2024 - Root cause
- Packaging process control
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- Evidence
- device-recall:cfres:209531
- Product
- Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
- Join
- Official recall number ·
Z-3115-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208948
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
- Join
- Official recall number ·
Z-2592-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208954
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60
- Join
- Official recall number ·
Z-2598-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:209596
- Product
- Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
- Join
- Official recall number ·
Z-2716-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:208966
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
- Join
- Official recall number ·
Z-2610-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:209241
- Product
- ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
- Join
- Official recall number ·
Z-2587-2024 - Root cause
- Labeling design
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- Evidence
- device-recall:cfres:209787
- Product
- Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
- Join
- Official recall number ·
Z-3185-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:209921
- Product
- Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
- Join
- Official recall number ·
Z-3196-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:209687
- Product
- HAWK Advanced Hypothermia Management Set, Item Number: 59-320
- Join
- Official recall number ·
Z-3182-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:209645
- Product
- CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
- Join
- Official recall number ·
Z-3136-2024 - Root cause
- Software design
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- Evidence
- device-recall:cfres:209923
- Product
- Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
- Join
- Official recall number ·
Z-3198-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:209686
- Product
- HAWK Warming Grid, Item Number: 59-300
- Join
- Official recall number ·
Z-3181-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:209117
- Product
- Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
- Join
- Official recall number ·
Z-2622-2024 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:208997
- Product
- HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3 System Controller, OUS, Model: 106531INT; HeartMate 3 System Controller Low Flow 2.0, Global, Model: 106531LF2
- Join
- Official recall number ·
Z-2583-2024 - Root cause
- Process design
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- Evidence
- device-recall:cfres:209071
- Product
- Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
- Join
- Official recall number ·
Z-2673-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208857
- Product
- BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
- Join
- Official recall number ·
Z-2682-2024 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:208974
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
- Join
- Official recall number ·
Z-2575-2024 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:208975
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.
- Join
- Official recall number ·
Z-2576-2024 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:209068
- Product
- Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Join
- Official recall number ·
Z-2670-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:208839
- Product
- Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
- Join
- Official recall number ·
Z-2586-2024 - Root cause
- Vendor change control
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- Evidence
- device-recall:cfres:208942
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.
- Join
- Official recall number ·
Z-2572-2024 - Root cause
- No Marketing Application
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- Evidence
- device-recall:cfres:209069
- Product
- Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
- Join
- Official recall number ·
Z-2671-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:209067
- Product
- Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Join
- Official recall number ·
Z-2669-2024 - Root cause
- Process control