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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 75 of 1581

Evidence Product Join Root cause
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:194528 LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip Official recall number · Z-1450-2022 Under Investigation by firm
device-recall:cfres:194217 BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) Official recall number · Z-1436-2022 Under Investigation by firm
device-recall:cfres:194706 Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 Official recall number · Z-1409-2022 Material/Component Contamination
device-recall:cfres:193835 ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393 (Abacus V3.3 ME). Commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400). Official recall number · Z-1376-2022 Software design
device-recall:cfres:193856 X80 RADiant Photoelectric Therapy System Official recall number · Z-1404-2022 Finished device change control
device-recall:cfres:194760 Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. Official recall number · Z-1413-2022 Nonconforming Material/Component
device-recall:cfres:194412 HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile) Official recall number · Z-1468-2022 Under Investigation by firm
device-recall:cfres:194527 Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm Official recall number · Z-1458-2022 Under Investigation by firm
device-recall:cfres:194709 Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures. Official recall number · Z-1478-2022 Process change 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:193263 In-Line ventilator adaptor Official recall number · Z-1139-2022 Device Design
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

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