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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 55 of 1581

Evidence Product Join Root cause
device-recall:cfres:198747 CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826 Official recall number · Z-1286-2023 Under Investigation by firm
device-recall:cfres:199838 TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities. Official recall number · Z-1573-2023 Software design
device-recall:cfres:199403 QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859 Official recall number · Z-1656-2023 Under Investigation by firm
device-recall:cfres:199622 Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G Official recall number · Z-1699-2023 Under Investigation by firm
device-recall:cfres:198948 Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula. Official recall number · Z-1468-2023 Process control
device-recall:cfres:199110 SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200 Official recall number · Z-1474-2023 Employee error
device-recall:cfres:200959 Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183 Official recall number · Z-2090-2023 Process control
device-recall:cfres:201137 SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated. Official recall number · Z-2075-2023 Under Investigation by firm
device-recall:cfres:200958 Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 Official recall number · Z-2089-2023 Process control
device-recall:cfres:199080 SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 Official recall number · Z-1317-2023 Process control
device-recall:cfres:198748 ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311 Official recall number · Z-1304-2023 Device Design
device-recall:cfres:198718 PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples Official recall number · Z-1295-2023 Under Investigation by firm
device-recall:cfres:199620 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692) Official recall number · Z-1427-2023 Nonconforming Material/Component
device-recall:cfres:199592 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE Official recall number · Z-1491-2023 Vendor change control
device-recall:cfres:199339 DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits Official recall number · Z-1582-2023 Labeling False and Misleading
device-recall:cfres:199409 STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 Official recall number · Z-1577-2023 Device Design
device-recall:cfres:199594 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE Official recall number · Z-1493-2023 Vendor change control
device-recall:cfres:199565 Anesthesia Set Coax 180, MP03384 Official recall number · Z-1458-2023 Process control
device-recall:cfres:199618 Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL Official recall number · Z-1607-2023 Under Investigation by firm
device-recall:cfres:199582 WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package) Official recall number · Z-1593-2023 Process control
device-recall:cfres:199544 VentStar Watertrap (P) 180 w/oLL, MP00362 Official recall number · Z-1443-2023 Process control
device-recall:cfres:200680 QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating Official recall number · Z-1643-2023 Pending
device-recall:cfres:199964 Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS) Official recall number · Z-1624-2023 Software design
device-recall:cfres:199397 BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905 Official recall number · Z-1636-2023 Pending
device-recall:cfres:199776 binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101 Official recall number · Z-1626-2023 Under Investigation by firm

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