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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 1502 of 1581

Evidence Product Join Root cause
device-recall:cfres:170671 Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0901-2019 Unknown/Undetermined by firm
device-recall:cfres:170553 Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 Official recall number · Z-0938-2019 Under Investigation by firm
device-recall:cfres:170698 Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0928-2019 Unknown/Undetermined by firm
device-recall:cfres:170649 Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0879-2019 Unknown/Undetermined by firm
device-recall:cfres:170703 Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0931-2019 Unknown/Undetermined by firm
device-recall:cfres:170648 Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0878-2019 Unknown/Undetermined by firm
device-recall:cfres:170694 MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0924-2019 Unknown/Undetermined by firm
device-recall:cfres:170652 Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0882-2019 Unknown/Undetermined by firm
device-recall:cfres:170155 Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). Official recall number · Z-0852-2019 Labeling mix-ups
device-recall:cfres:165789 Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 Official recall number · Z-2937-2018 Process control
device-recall:cfres:166577 remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702 Official recall number · Z-3018-2018 Under Investigation by firm
device-recall:cfres:159474 Laparoscopy CDS Official recall number · Z-2978-2018 Under Investigation by firm
device-recall:cfres:165577 Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring Official recall number · Z-2580-2018 Component change control
device-recall:cfres:165580 CT Goldseal Optima CT 600 Official recall number · Z-2583-2018 Component change control
device-recall:cfres:165363 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium. Official recall number · Z-2545-2018 Unknown/Undetermined by firm
device-recall:cfres:165375 PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347) Official recall number · Z-2534-2018 Under Investigation by firm
device-recall:cfres:165341 Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred. Official recall number · Z-2529-2018 Nonconforming Material/Component
device-recall:cfres:165287 AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium Official recall number · Z-2912-2018 Package design/selection
device-recall:cfres:166164 GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems Official recall number · Z-2954-2018 Nonconforming Material/Component
device-recall:cfres:166484 Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765 Official recall number · Z-2962-2018 Equipment maintenance
device-recall:cfres:165159 ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S Official recall number · Z-2444-2018 Packaging change control
device-recall:cfres:165110 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 Official recall number · Z-2453-2018 Package design/selection
device-recall:cfres:165420 Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT Official recall number · Z-2513-2018 Process control
device-recall:cfres:165115 PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 Official recall number · Z-2458-2018 Package design/selection
device-recall:cfres:165413 Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM Official recall number · Z-2506-2018 Process control

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