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 313 of 1190
FDA device recalls, page 313 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0690-2021Class IIFive IceRod" i-Thaw" Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0689-2021Class IIFive IceSphere" Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0688-2021Class IIIceRod" Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0687-2021Class IIIceSeed" Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0686-2021Class IIIceRod" i-Thaw" Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0685-2021Class IIThree IcePearl" 2.1 CX Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0684-2021Class IIThree IceFORCE" 2.1 CX Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0683-2021Class IIIcePearl" 2.1 CX Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0682-2021Class IIIceFORCE" 2.1 CX Prostate Cryoablation KitBoston Scientific CorporationGEH
Z-0681-2021Class IIIceSeed" 1.5 MRI Cryoablation NeedleBoston Scientific CorporationGEH
Z-0680-2021Class IIIceSeed" 1.5 MRI 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0679-2021Class IIIceRod" 1.5 MRI Cryoablation NeedleBoston Scientific CorporationGEH
Z-0678-2021Class IIIceRod" 1.5 MRI 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0677-2021Class IIIceEDGE" 2.4 90p Cryoablation NeedleBoston Scientific CorporationGEH
Z-0676-2021Class IIIceSeed" 1.5 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0675-2021Class IIIceSeed" 1.5 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0674-2021Class IIIceSphere" 1.5 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0673-2021Class IIIceSphere" 1.5 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0672-2021Class IIIceSphere" 1.5 S 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0671-2021Class IIIceSphere" 1.5 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0670-2021Class IIIceSphere" 1.5 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0669-2021Class IIIceRod" 1.5 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0668-2021Class IIIceRod" 1.5 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0667-2021Class IIIceRod" 1.5 PLUS Cryoablation NeedleBoston Scientific CorporationGEH
Z-0666-2021Class IIIceRod" 1.5 PLUS 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0665-2021Class IIIceRod" 1.5 i-Thaw" Cryoablation NeedleBoston Scientific CorporationGEH
Z-0664-2021Class IIIceSphere" 1.5 CX 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0663-2021Class IIIceRod" 1.5 CX 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0662-2021Class IIIcePearl" 2.1 CX L 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0661-2021Class IIIcePearl" 2.1 CX Cryoablation NeedleBoston Scientific CorporationGEH
Z-0660-2021Class IIIcePearl" 2.1 CX 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0659-2021Class IIIceFORCE" 2.1 CX L 90 Cryoablation NeedleBoston Scientific CorporationGEI
Z-0658-2021Class IIIceFORCE" 2.1 CX Cryoablation NeedleBoston Scientific CorporationGEH
Z-0657-2021Class IIIceFORCE" 2.1 CX 90 Cryoablation NeedleBoston Scientific CorporationGEH
Z-0736-2021Class ILotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...Boston Scientific CorporationNPT
Z-0735-2021Class ILotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...Boston Scientific CorporationNPT
Z-0734-2021Class ILotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...Boston Scientific CorporationNPT
Z-0730-2021Class ILotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...Boston Scientific CorporationNPT
Z-0729-2021Class ILotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...Boston Scientific CorporationNPT
Z-0728-2021Class ILotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...Boston Scientific CorporationNPT
Z-0564-2021Class IITempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product...Remote Diagnostic Technologies Ltd.LDD
Z-0570-2021Class IIPolaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral...Zimmer GmbHNKB
Z-0758-2021Class IIContour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090...Boston Scientific CorporationFAD
Z-0757-2021Class IIContour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570Boston Scientific CorporationFAD
Z-0515-2021Class IICapnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01...Medtronic, Inc.CCK
Z-0568-2021Class IICenteze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis...Galt Medical CorpKGZ
Z-0928-2021Class IIMedtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber...Medtronic, Inc.NIK
Z-0927-2021Class IIMedtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter...Medtronic, Inc.NIK
Z-0926-2021Class IIMedtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional...Medtronic, Inc.NIK
Z-0879-2021Class IEMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter...Boston Scientific CorporationLWS