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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 1 of 1581

Evidence Product Join Root cause
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:198976 Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DBM T44115INT 15CC GRAFTON CRUNCH, REF T44115INT; Demineralized Bone Matrix (DBM) product Official recall number · Z-1324-2023 Process control
device-recall:cfres:199047 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities Official recall number · Z-1342-2023 Under Investigation by firm
device-recall:cfres:199644 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12 Official recall number · Z-1522-2023 Labeling design
device-recall:cfres:199553 Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System Official recall number · Z-1500-2023 Other
device-recall:cfres:199317 Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01 Official recall number · Z-1482-2023 Process change control
device-recall:cfres:199664 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60 Official recall number · Z-1542-2023 Labeling design
device-recall:cfres:198321 Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 Official recall number · Z-1148-2023 Software design
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: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
device-recall:cfres:197680 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass. Official recall number · Z-1024-2023 Process change control
device-recall:cfres:197607 Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405 Official recall number · Z-1019-2023 Under Investigation by firm
device-recall:cfres:197682 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass. Official recall number · Z-1026-2023 Process change control
device-recall:cfres:197510 TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile. Official recall number · Z-1107-2023 Device Design
device-recall:cfres:198009 Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A Official recall number · Z-1109-2023 Under Investigation by firm
device-recall:cfres:198117 WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0 Official recall number · Z-1102-2023 Process design

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