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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 16 of 1581

Evidence Product Join Root cause
device-recall:cfres:189592 Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack Official recall number · Z-0119-2022 Device Design
device-recall:cfres:189607 REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845 Official recall number · Z-0160-2022 Mixed-up of materials/components
device-recall:cfres:188960 Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749 Official recall number · Z-0146-2022 Other
device-recall:cfres:189265 Pneupac paraPac plus 300 ventilator kit, REF P300NGB Official recall number · Z-0163-2022 Process control
device-recall:cfres:189506 6.5MMX165MM CANNULATED SCREW Official recall number · Z-0143-2022 Process control
device-recall:cfres:189354 REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US Official recall number · Z-0169-2022 Software change control
device-recall:cfres:189021 Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. Official recall number · Z-0015-2022 Process change control
device-recall:cfres:189109 Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits: Official recall number · Z-0010-2022 Process control
device-recall:cfres:189436 Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.) Official recall number · Z-0058-2022 Labeling design
device-recall:cfres:189251 Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275 Official recall number · Z-0049-2022 Labeling design
device-recall:cfres:189139 ARCH Leg Positioning System Official recall number · Z-0072-2022 Device Design
device-recall:cfres:189103 CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices. Official recall number · Z-0069-2022 Under Investigation by firm
device-recall:cfres:189276 AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103 Official recall number · Z-0073-2022 Software Manufacturing/Software Deployment
device-recall:cfres:189456 McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS Official recall number · Z-0205-2022 Nonconforming Material/Component
device-recall:cfres:189458 McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS Official recall number · Z-0207-2022 Nonconforming Material/Component
device-recall:cfres:189748 ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, Official recall number · Z-0198-2022 Packaging change control
device-recall:cfres:189209 Discovery MR750 3.0T nuclear magnetic resonance imaging system Official recall number · Z-0136-2022 Software design
device-recall:cfres:189227 smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092 Official recall number · Z-0101-2022 Component design/selection
device-recall:cfres:189229 smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 Official recall number · Z-0103-2022 Component design/selection
device-recall:cfres:189033 MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868 Official recall number · Z-0122-2022 Device Design
device-recall:cfres:189113 Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic Official recall number · Z-0004-2022 Device Design
device-recall:cfres:189148 ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs Official recall number · Z-0067-2022 Process control
device-recall:cfres:189212 SIGNA Artist nuclear magnetic resonance imaging system Official recall number · Z-0139-2022 Software design
device-recall:cfres:189092 EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208 Official recall number · Z-2583-2021 Process control
device-recall:cfres:189291 Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. Official recall number · Z-0003-2022 Under Investigation by firm

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