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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 15 of 1581

Evidence Product Join Root cause
device-recall:cfres:193361 MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R Official recall number · Z-1087-2022 Mixed-up of materials/components
device-recall:cfres:192967 Regard brand CABG Pack A and B - Spartanburg Official recall number · Z-1051-2022 Under Investigation by firm
device-recall:cfres:194132 Clean Catch Urine Kit NS 178489, AHMU58A Official recall number · Z-1276-2022 Process control
device-recall:cfres:194356 NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 Official recall number · Z-1311-2022 Under Investigation by firm
device-recall:cfres:194323 Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A Official recall number · Z-1309-2022 Component design/selection
device-recall:cfres:194092 regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. Official recall number · Z-1295-2022 Process change control
device-recall:cfres:192681 Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379. Product Code/UDI /Description: 85320 650862853209 Advanta V12 Covered Stent, 5mm x 38mm x 80cm; 85321 650862853216 Advanta V12 Covered Stent, 5mm x 59mm x 80cm; 85322 650862853223 Advanta V12 Covered Stent, 6mm x 38mm x 80cm; 85323 650862853230 Advanta V12 Covered Stent, 6mm x 59mm x 80cm 85324 650862853247 Advanta V12 Covered Stent, 7mm x 38mm x 80cm; 85325 650862853254 Advanta V12 Covered Stent, 7mm x 59mm x 80cm; 85326 650862853261 Advanta V12 Covered Stent, 8mm x 38mm x 80cm; 85327 650862853278 Advanta V12 Covered Stent, 8mm x 59mm x 80cm; 85328 650862853285 Advanta V12 Covered Stent, 9mm x 38mm x 80cm; 85329 650862853292 Advanta V12 Covered Stent, 9mm x 59mm x 80cm; 85330 650862853308 Advanta V12 Covered Stent, 5mm x 38mm x120cm; 85331 650862853315 Advanta V12 Covered Stent, 5mm x 59mm x120cm; 85332 650862853322 Advanta V12 Covered Stent, 6mm x 38mm x120cm; 85333 650862853339 Advanta V12 Covered Stent, 6mm x 59mm x120cm; 85334 650862853346 Advanta V12 Covered Stent, 7mm x 38mm x120cm; 85335 650862853353 Advanta V12 Covered Stent, 7mm x 59mm x120cm; 85336 650862853360 Advanta V12 Covered Stent, 8mm x 38mm x120cm; 85337 650862853377 Advanta V12 Covered Stent, 8mm x 59mm x120cm; 85338 650862853384 Advanta V12 Covered Stent, 9mm x 38mm x120cm; 85339 650862853391 Advanta V12 Covered Stent, 9mm x 59mm x120cm; 85340 650862853407 Advanta V12 Covered Stent, 5mm x 16mm x 80cm; 85341 650862853414 Advanta V12 Covered Stent, 5mm x 22mm x 80cm; 85342 650862853421 Advanta V12 Covered Stent, 6mm x 16mm x 80cm; 85343 650862853438 Advanta V12 Covered Stent, 6mm x 22mm x 80cm; 85344 650862853445 Advanta V12 Covered Stent, 7mm x 16mm x 80cm; 85345 650862853452 Advanta V12 Covered Stent, 7mm x 22mm x 80cm; 85350 650862853506 Advanta V12 Covered Stent, 5mm x 16mm x 120cm; 85351 650862853513 Advanta V12 Covered Stent, 5mm x 22mm x 120cm; 85352 650862853520 Advanta V12 Covered Stent, 6mm x 16mm x 120cm; 85353 650862853537 Advanta V12 Covered Stent, 6mm x 22mm x 120cm; 85354 650862853544 Advanta V12 Covered Stent, 7mm x 16mm x 120cm; 85355 650862853551 Advanta V12 Covered Stent, 7mm x 22mm x 120cm; 85360 650862853605 Advanta V12 Covered Stent, 10mm x 38mm x 80cm; 85361 650862853612 Advanta V12 Covered Stent, 10mm x 59mm x 80cm; 85364 650862853643 Advanta V12 Covered Stent, 10mm x 38mm x 120cm; 85365 650862853650 Advanta V12 Covered Stent, 10mm x 59mm x 120cm; 85370 650862853704 Advanta V12 Large Diameter, 12mm x 29mm x 80cm; 85371 650862853711 Advanta V12 Large Diameter, 12mm x 41mm x 80cm; 85372 650862853728 Advanta V12 Large Diameter, 12mm x 61mm x 80cm; 85379 650862853797 Advanta V12 Large Diameter, 12mm x 29mm x 120cm; 85388 650862853889 Advanta V12 Covered Stent, 5mm x 32mm x 80cm; ;85390 650862853902 Advanta V12 Covered Stent, 7mm x 32mm x 80cm; 85391 650862853919 Advanta V12 Covered Stent, 8mm x 32mm x 80cm; 85392 650862853926 Advanta V12 Covered Stent, 9mm x 32mm x 80cm; 85394 650862853940 Advanta V12 Covered Stent, 5mm x 32mm x 120cm; 85395 650862853957 Advanta V12 Covered Stent, 6mm x 32mm x 120cm. 85396 650862853964 Advanta V12 Covered Stent, 7mm x 32mm x 120cm 85397 650862853971 Advanta V12 Covered Stent, 8mm x 32mm x 120cm 85398 650862853988 Advanta V12 Covered Stent, 9mm x 32mm x 120cm Official recall number · Z-1076-2022 Device Design
device-recall:cfres:192990 Sara Plus Active Floor Lift Official recall number · Z-1098-2022 Device Design
device-recall:cfres:193222 VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap. Official recall number · Z-1108-2022 Process control
device-recall:cfres:193012 Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy. Official recall number · Z-1123-2022 Under Investigation by firm
device-recall:cfres:193223 SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. Official recall number · Z-1134-2022 Under Investigation by firm
device-recall:cfres:193255 AC-powered adjustable medical beds with built-in electric DC actuators and controls. Official recall number · Z-1136-2022 Nonconforming Material/Component
device-recall:cfres:193159 (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile. Official recall number · Z-1126-2022 Device Design
device-recall:cfres:193286 Epidural Tray Catalog 1577 Official recall number · Z-1155-2022 Other
device-recall:cfres:193510 INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right Official recall number · Z-1133-2022 Under Investigation by firm
device-recall:cfres:193334 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360 Official recall number · Z-1185-2022 Other
device-recall:cfres:193301 MBB Tray Catalog Number: 9882 Official recall number · Z-1163-2022 Other
device-recall:cfres:193340 SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1 Official recall number · Z-1188-2022 Other
device-recall:cfres:193556 Centricity PACS RA1000 Official recall number · Z-1233-2022 Software design
device-recall:cfres:193567 XVIVO Organ Chamber REF 19020 Official recall number · Z-1212-2022 Under Investigation by firm
device-recall:cfres:193530 MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS Official recall number · Z-1220-2022 Under Investigation by firm
device-recall:cfres:193256 Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit Official recall number · Z-1216-2022 Device Design
device-recall:cfres:193177 BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry. Official recall number · Z-1215-2022 Process control
device-recall:cfres:189522 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 Official recall number · Z-0180-2022 Software design
device-recall:cfres:188883 Bivona Aire-Cuf Endotracheal Tube Official recall number · Z-0177-2022 Process control