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:207397
- Product
- Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
- Join
- Official recall number ·
Z-1853-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:207341
- Product
- Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
- Join
- Official recall number ·
Z-1837-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:207153
- Product
- Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
- Join
- Official recall number ·
Z-1822-2024 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:207175
- Product
- CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
- Join
- Official recall number ·
Z-1835-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206812
- Product
- ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-06
- Join
- Official recall number ·
Z-1716-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:207140
- Product
- RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
- Join
- Official recall number ·
Z-1748-2024 - Root cause
- Software design
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- Evidence
- device-recall:cfres:206815
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-12
- Join
- Official recall number ·
Z-1719-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206745
- Product
- PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis).
- Join
- Official recall number ·
Z-1758-2024 - Root cause
- Process design
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- Evidence
- device-recall:cfres:207144
- Product
- RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
- Join
- Official recall number ·
Z-1752-2024 - Root cause
- Software design
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- Evidence
- device-recall:cfres:206901
- Product
- Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
- Join
- Official recall number ·
Z-1739-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206993
- Product
- Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
- Join
- Official recall number ·
Z-1697-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:206630
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
- Join
- Official recall number ·
Z-1641-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206644
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter
- Join
- Official recall number ·
Z-1654-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206797
- Product
- Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Join
- Official recall number ·
Z-1799-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:206662
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter
- Join
- Official recall number ·
Z-1672-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206646
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
- Join
- Official recall number ·
Z-1656-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206670
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
- Join
- Official recall number ·
Z-1679-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:206639
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
- Join
- Official recall number ·
Z-1650-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:207098
- Product
- TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
- Join
- Official recall number ·
Z-1791-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:207180
- Product
- Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
- Join
- Official recall number ·
Z-1776-2024 - Root cause
- Software design
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- Evidence
- device-recall:cfres:206792
- Product
- Medtronic Clearview Blower/Mister, Model Number 22120
- Join
- Official recall number ·
Z-1794-2024 - Root cause
- Process control
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- Evidence
- device-recall:cfres:207441
- Product
- BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
- Join
- Official recall number ·
Z-1930-2024 - Root cause
- Component design/selection
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- Evidence
- device-recall:cfres:207253
- Product
- Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
- Join
- Official recall number ·
Z-1909-2024 - Root cause
- Process design
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- Evidence
- device-recall:cfres:207506
- Product
- MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
- Join
- Official recall number ·
Z-1937-2024 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:207284
- Product
- Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1
- Join
- Official recall number ·
Z-1936-2024 - Root cause
- Under Investigation by firm