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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 6 of 1581

Evidence Product Join Root cause
device-recall:cfres:195311 Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart) Official recall number · Z-1568-2022 Device Design
device-recall:cfres:195695 Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355 Official recall number · Z-1645-2022 Device Design
device-recall:cfres:195164 NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021. Official recall number · Z-1561-2022 Nonconforming Material/Component
device-recall:cfres:194612 MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200 Official recall number · Z-1610-2022 Environmental control
device-recall:cfres:195403 Nobel Biocare N1 TiUltra TCC NP 3.5x13mm Official recall number · Z-1565-2022 Process change control
device-recall:cfres:195034 VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9 Official recall number · Z-1640-2022 Software design
device-recall:cfres:194747 a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400. e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LNG LIFE GL (4GL/CS) Catalog # 10-2800 Official recall number · Z-1614-2022 Environmental control
device-recall:cfres:194630 SX-One MicroKnife Official recall number · Z-1387-2022 Process control
device-recall:cfres:194410 Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512 Official recall number · Z-1384-2022 Labeling Change Control
device-recall:cfres:193884 PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. Official recall number · Z-1363-2022 Process design
device-recall:cfres:194536 ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery. Official recall number · Z-1391-2022 Device Design
device-recall:cfres:194252 CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 Official recall number · Z-1347-2022 Unknown/Undetermined by firm
device-recall:cfres:194830 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1 Official recall number · Z-1488-2022 Device Design
device-recall:cfres:194722 (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479. Official recall number · Z-1517-2022 Process control
device-recall:cfres:194788 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1 Official recall number · Z-1486-2022 Device Design
device-recall:cfres:195341 cobas e801 Immunoassay Analyzer Official recall number · Z-1515-2022 Software design
device-recall:cfres:192765 ACS IR - Angio Pack Official recall number · Z-1038-2022 Process control
device-recall:cfres:192184 First SIGN SARS-CoV-2 Antigen Test Official recall number · Z-0892-2022 No Marketing Application
device-recall:cfres:192841 Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother. Official recall number · Z-1005-2022 Nonconforming Material/Component
device-recall:cfres:192759 Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother. Official recall number · Z-1004-2022 Nonconforming Material/Component
device-recall:cfres:190389 DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US, Official recall number · Z-0825-2022 Labeling design
device-recall:cfres:192298 NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250 Official recall number · Z-0823-2022 Under Investigation by firm
device-recall:cfres:192167 TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A Official recall number · Z-0814-2022 Under Investigation by firm
device-recall:cfres:191620 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Official recall number · Z-0803-2022 Labeling Change Control
device-recall:cfres:191799 SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 Official recall number · Z-0789-2022 Process control