Medical Device
Manufacturing
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 1147 of 1190
FDA device recalls, page 1147 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1178-04Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System...Cook IncorporatedMIH
Z-1177-04Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System...Cook IncorporatedMIH
Z-1176-04Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System...Cook IncorporatedMIH
Z-1175-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1174-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1173-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1172-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1171-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1170-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1169-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1168-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1167-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1166-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1165-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1164-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1163-04Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer...Cook IncorporatedMIH
Z-1162-04Cook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Transitionless Peel-Away IntroducerCook IncorporatedMIH
Z-1161-04Cook brand Zenith AAA Endovascular Graft Iliac Leg Extensions - diameter 14 mm - length...Cook IncorporatedMIH
Z-1160-04Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded...Cook IncorporatedMIH
Z-1047-04VIDAS CMV IgG AssaybioMerieux, Inc.LFZ
Z-1308-04ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507...Philips North America LLCLLZ
Z-1307-04MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 9896 001 41502Philips North America LLCIZI
Z-1306-04EasyDiagnost Eleva Part Number 989605071921Philips North America LLCKPR
Z-1024-04Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.Medtronic, Inc.LOX
Z-1333-04Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through...Welch Allyn Protocol, Inc.DQA
Z-1046-04Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave...Arjo, Inc.FSA
Z-1476-04Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041Siemens Medical Solutions USA, Inc.JAA
Z-1475-04Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466033Siemens Medical Solutions USA, Inc.JAA
Z-1300-04ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1053-04Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194...Ortho-Clinical Diagnostics, Inc.MMI
Z-1305-04Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.Siemens Healthcare Diagnostics Inc.KFF
Z-0212-05Lift Chairs. Electric Positioning Chair.Pride Mobility Products CorpINO
Z-1043-04Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing...Lang Dental Mfg Co, Inc.EBI
Z-1042-04Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under...Lang Dental Mfg Co, Inc.EBG
Z-1041-04Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code...Lang Dental Mfg Co, Inc.EBG
Z-1313-04Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38%...The Contact Lens Store, Inc.LPL
Z-1055-04LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and...Ethicon Endo-Surgery IncGDO
Z-1045-04Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and...Canon Medical Systems USA, Inc.LNH
Z-0289-06Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223Bio-Rad Laboratories Inc.DIO
Z-1220-04Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900...Respironics, Inc.BZQ
Z-1073-04TefGen is an implant material which is intended to be used as a temporary space-making...Lifecore Biomedical LLCLYC
Z-1066-04Surgical powered laser instrument, used for photocoagulation of ocular tissues in the...Carl Zeiss Meditec IncGEX
Z-1108-04SIEMENS AXIOM Artis - AUTOMAP FUNCTIONSiemens Medical Solutions USA, Inc.IZI
Z-1059-04Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A...Canon Medical Systems USA, Inc.KPS
Z-1039-04Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box...QiagenLSO
Z-1229-04TDx/TDxFLx Opiates Reagent, Product list number: 9673-60Abbott Diagnostic International, Ltd.DJG
Z-1030-04Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC...Boston Scientific CorporationKOC
Z-1029-04Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12...Boston Scientific CorporationKOC
Z-0547-05PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission...Siemens Medical Solutions USA, Inc.KPS
Z-1084-04Linear accelerator workstation software suiteVarian Medical Systems, Inc.IYE