510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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

59,486 records, page 867 of 1190
FDA device recalls, page 867 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1377-2011GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body...GE HealthcareLNH
Z-1376-2011GE Healthcare Discovery MR450 1.5T, The Discovery MR450 is a whole body magnetic...GE HealthcareLNH
Z-1375-2011GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic...GE HealthcareLNH
Z-0171-2012***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using...ZimVie US Corp LLCDZE
Z-0866-2011Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluidsMerit Medical Systems, Inc.gbx
Z-0933-2011Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication...Baxter Healthcare CorporationFRN
Z-0719-2011Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc...C.R. Bard IncEXS
Z-1972-2011UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600...Siemens Healthcare Diagnostics Inc.JJE
Z-2582-2011XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create...Elekta LimitedMUJ
Z-1065-2011Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent...Leica Microsystems, Inc.NJT
Z-1333-2011Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By...Vygon MfgFPA
Z-1332-2011FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First Medical...Vygon MfgFPA
Z-1331-2011Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1 Intended...Vygon MfgFPA
Z-1330-2011Churchill Medical Systems 14"Extension Set with SmartSite Injection Item #...Vygon MfgFPA
Z-1329-2011Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451 Intended use...Vygon MfgFPA
Z-1328-2011Walkmed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection...Vygon MfgFPA
Z-1327-2011Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety...Vygon MfgFPA
Z-1326-2011Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with...Vygon MfgFPA
Z-1325-2011Churchill Medical 78" Stopcock Extension Set with male/female red cap; item #...Vygon MfgFPA
Z-1324-2011WalkMed Infusion 100" 20 drop IV Administration Set with 1 Needlefree Y-site and Free...Vygon MfgFPA
Z-1323-2011Churchill Medical Systems Central Line Dressing Kit; Item # AMS-8316CP-1 Intended use...Vygon MfgFPA
Z-1322-2011WalkMed Infusion Triton 90" 20 drop IV Administration Set; Manufactured for Walked...Vygon MfgFPA
Z-1321-2011WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and...Vygon MfgFPA
Z-1320-2011WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site Item #...Vygon MfgFPA
Z-1319-2011WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and...Vygon MfgFPA
Z-0842-2011AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm...Spectranetics Corp.DQY
Z-0841-2011AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm...Spectranetics Corp.DQY
Z-0840-2011AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm...Spectranetics Corp.DQY
Z-0839-2011AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm...Spectranetics Corp.DQY
Z-0838-2011AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm...Spectranetics Corp.DQY
Z-0964-2012Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.Alere San Diego, Inc.CHH
Z-0569-2011MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 5 ml in 12 ml syringe Item...Medtronic, Inc.NGT
Z-0568-2011MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 3 ml in 12 ml syringe Item...Medtronic, Inc.NGT
Z-0567-2011MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 10 ml in 12 ml syringe Item...Medtronic, Inc.NGT
Z-0566-2011MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item...Medtronic, Inc.NGT
Z-0565-2011MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item...Medtronic, Inc.NGT
Z-0564-2011MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 10 ml in 12 ml syringe Item...Medtronic, Inc.NGT
Z-1571-2011MONOJECT Blood Collection Tubes containing heparin 10x64 Sodium Heparin Item code...Medtronic, Inc.JKA
Z-1570-2011MONOJECT Blood Collection Tubes containing heparin 10x50 Sodium Heparin Item code...Medtronic, Inc.JKA
Z-1569-2011MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace...Medtronic, Inc.JKA
Z-0619-2011Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF...Zimmer GmbHHWT
Z-0965-2011SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany...LivaNova USA, Inc.DTQ
Z-0964-2011S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25...LivaNova USA, Inc.DTQ
Z-0963-2011SRD S5 Mast Roller Pump System 85, S5 Component, Part No.: 50-80-70, Made in Germany...LivaNova USA, Inc.DTQ
Z-0962-20112 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in...LivaNova USA, Inc.DTQ
Z-0961-2011SRD S5 Mast Roller Pump System 150, S5 Component, Part No.: 50-80-00, Made in Germany...LivaNova USA, Inc.DTQ
Z-0960-2011S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland...LivaNova USA, Inc.DTQ
Z-0959-2011S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh...LivaNova USA, Inc.DTQ
Z-0958-2011S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh...LivaNova USA, Inc.DTQ
Z-0957-2011Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh...LivaNova USA, Inc.DTQ