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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 62 of 1581

Evidence Product Join Root cause
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: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:198099 SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile Official recall number · Z-1135-2023 Process control
device-recall:cfres:197587 iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE Official recall number · Z-1133-2023 Process control
device-recall:cfres:198121 FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147 Official recall number · Z-1059-2023 Labeling Change Control
device-recall:cfres:197593 GORE CARDIOFORM Septal Occluder, REF: GSX0030A Official recall number · Z-1048-2023 Employee error
device-recall:cfres:198492 Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090 Official recall number · Z-1249-2023 Device Design
device-recall:cfres:199178 EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 Official recall number · Z-1384-2023 Process change control
device-recall:cfres:199205 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure Official recall number · Z-1385-2023 Process change control
device-recall:cfres:199085 Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203) Official recall number · Z-1388-2023 Process control
device-recall:cfres:198921 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 Official recall number · Z-1417-2023 Software design
device-recall:cfres:199270 MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device Official recall number · Z-1405-2023 Under Investigation by firm
device-recall:cfres:199107 ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe Official recall number · Z-1420-2023 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: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:198419 Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471 Official recall number · Z-1167-2023 Software design
device-recall:cfres:198189 Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3 Official recall number · Z-1183-2023 Under Investigation by firm
device-recall:cfres:197512 Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6 8886 4410-13 NOVAFIL 6-0 BLU 45CM P10 8886 4410-03 NOVAFIL 7-0 BLU 45CM P10 8886 4422-43 NOVAFIL 3-0 BLU 45CM C14 8886 4424-51 NOVAFIL 2-0 BLU 75CM C16 8886 4450-41 NOVAFIL 3-0 BLU 75CM V26 8886 4452-51 NOVAFIL 2-0 BLU 75CM V20 8886 4459-61 NOVAFIL 0 BLU 75CM GS22 8886 4470-81 NOVAFIL* 2 BLU 150CM GS26 8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14 SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12 SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12 SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12 SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12 SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12 SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13 SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12 SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12 Official recall number · Z-1175-2023 Packaging process control
device-recall:cfres:197604 MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use. Official recall number · Z-1014-2023 Process control

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