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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 19 of 1581

Evidence Product Join Root cause
device-recall:cfres:186205 ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit Official recall number · Z-1412-2021 Under Investigation by firm
device-recall:cfres:186958 Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US. Official recall number · Z-1612-2021 Under Investigation by firm
device-recall:cfres:186140 Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Official recall number · Z-1507-2021 Software design
device-recall:cfres:186712 VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing. Official recall number · Z-1534-2021 Process control
device-recall:cfres:186693 Regard Dressing Change Tray Official recall number · Z-1542-2021 Package design/selection
device-recall:cfres:186350 Pro Series Fertility Device (SKU 644042788139) Official recall number · Z-1363-2021 No Marketing Application
device-recall:cfres:186001 EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. Official recall number · Z-1352-2021 Process control
device-recall:cfres:186167 ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11 Official recall number · Z-1387-2021 Under Investigation by firm
device-recall:cfres:186376 CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524 Official recall number · Z-1354-2021 Labeling Change Control
device-recall:cfres:186307 Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids. Official recall number · Z-1487-2021 Device Design
device-recall:cfres:186306 BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. Official recall number · Z-1460-2021 Device Design
device-recall:cfres:186311 BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. Official recall number · Z-1462-2021 Device Design
device-recall:cfres:186877 Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B Official recall number · Z-1557-2021 Package design/selection
device-recall:cfres:187011 RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system Official recall number · Z-1597-2021 Software design
device-recall:cfres:186823 REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1579-2021 Component design/selection
device-recall:cfres:186824 REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1580-2021 Component design/selection
device-recall:cfres:186816 REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein). Official recall number · Z-1573-2021 Component design/selection
device-recall:cfres:186876 Kit: Midline Insertion DA. MAI Kit Part Number: 77981B Official recall number · Z-1556-2021 Package design/selection
device-recall:cfres:186818 REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1574-2021 Component design/selection
device-recall:cfres:187127 NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 Official recall number · Z-1549-2021 Process change control
device-recall:cfres:186940 Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Official recall number · Z-1602-2021 Under Investigation by firm
device-recall:cfres:186902 GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings. Official recall number · Z-1672-2021 Device Design
device-recall:cfres:186706 REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central venous catheterization is prescribed. Official recall number · Z-1663-2021 Process control
device-recall:cfres:186713 REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed. Official recall number · Z-1668-2021 Process control
device-recall:cfres:186942 Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Official recall number · Z-1604-2021 Under Investigation by firm

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