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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 14 of 1581

Evidence Product Join Root cause
device-recall:cfres:196899 DeRoyal GU ROBOTIC PACK, REF 89-7063.12 Official recall number · Z-0585-2023 Nonconforming Material/Component
device-recall:cfres:196824 HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, Official recall number · Z-0523-2023 Packaging process control
device-recall:cfres:196785 BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray Official recall number · Z-0484-2023 Packaging process control
device-recall:cfres:196827 HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 Official recall number · Z-0526-2023 Packaging process control
device-recall:cfres:197007 DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01 Official recall number · Z-0692-2023 Nonconforming Material/Component
device-recall:cfres:197166 Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump Official recall number · Z-0445-2023 Pending
device-recall:cfres:196927 DeRoyal SPINE PACK, REF 89-8361.08 Official recall number · Z-0613-2023 Nonconforming Material/Component
device-recall:cfres:196522 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump Official recall number · Z-0426-2023 Pending
device-recall:cfres:196977 DeRoyal BIOPSY PACK, REF 89-9614.07 Official recall number · Z-0662-2023 Nonconforming Material/Component
device-recall:cfres:197232 DeRoyal CATARACT PACK, REF 89-10086.05 Official recall number · Z-0715-2023 Nonconforming Material/Component
device-recall:cfres:196917 DeRoyal EYE TRAY PGYBK, REF 89-7978.02 Official recall number · Z-0603-2023 Nonconforming Material/Component
device-recall:cfres:196911 DeRoyal SPINAL FUSION PACK, REF 89-7515.13 Official recall number · Z-0597-2023 Nonconforming Material/Component
device-recall:cfres:196324 Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113 Official recall number · Z-0383-2023 Under Investigation by firm
device-recall:cfres:196336 CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015 Official recall number · Z-0395-2023 Under Investigation by firm
device-recall:cfres:196318 Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040 Official recall number · Z-0378-2023 Under Investigation by firm
device-recall:cfres:196325 Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300 Official recall number · Z-0384-2023 Under Investigation by firm
device-recall:cfres:181823 Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 Official recall number · Z-2507-2020 Software design
device-recall:cfres:181788 DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system. Official recall number · Z-2497-2020 Software design
device-recall:cfres:181822 Patient Connector, Model Number 24967 Official recall number · Z-2506-2020 Software design
device-recall:cfres:181776 Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 Official recall number · Z-2500-2020 Process design
device-recall:cfres:180336 BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors. Official recall number · Z-2479-2020 Software design (manufacturing process)
device-recall:cfres:193263 In-Line ventilator adaptor Official recall number · Z-1139-2022 Device Design
device-recall:cfres:193400 Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) Official recall number · Z-1240-2022 Under Investigation by firm
device-recall:cfres:193594 Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A Official recall number · Z-1280-2022 Nonconforming Material/Component
device-recall:cfres:193088 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) Official recall number · Z-1066-2022 Under Investigation by firm