510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,336 records, page 10 of 1187
FDA device recalls, page 10 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2879-2026Class IINFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD...Boston Scientific Neuromodulation CorporationLGW
Z-2854-2026Class IIBrand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version...Copan WASPJQP
Z-2941-2026Class II60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext...BD Switzerland SARLFPA
Z-2778-2026Class IIMiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)Medtronic, Inc.NDC
Z-2776-2026Class IIOlympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4OLYMPUS Corporation of the AmericasHIF
Z-2644-2026Class IICyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer...Accuray IncorporatedIYE
Z-2640-2026Class IICyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer...Accuray IncorporatedIYE
Z-2908-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number...Tissium SASFD
Z-2907-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number...Tissium SASFD
Z-2906-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number...Tissium SASFD
Z-2905-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number...Tissium SASFD
Z-2904-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number...Tissium SASFD
Z-2903-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number...Tissium SASFD
Z-2902-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number...Tissium SASFD
Z-2901-2026Class IIBrand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number...Tissium SASFD
Z-2804-2026Class IIL-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620Argon Medical Devices, IncLJS
Z-2803-2026Class IIL-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF...Argon Medical Devices, IncLJS
Z-2953-2026Class IIOne-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.Intersurgical Ltd.CAE
Z-2952-2026Class IIOne-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.Intersurgical Ltd.CAE
Z-2930-2026Class IIGLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The...Terumo Medical Corp.DYB
Z-3063-2026Class IIMedline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-3062-2026Class IIMedline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3061-2026Class IIMedline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-3060-2026Class IIMedline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702BMEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-3059-2026Class IIMedline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-3058-2026Class IIMedline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-3057-2026Class IIMedline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-3056-2026Class IIMedline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-3055-2026Class IIMedline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-3054-2026Class IIMedline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-3053-2026Class IIMedline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375CMEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-3052-2026Class IIMedline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437DMEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-3051-2026Class IIMedline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-3050-2026Class IIMedline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-3049-2026Class IIMedline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-3048-2026Class IIMedline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2)...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2746-2026Class IIST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement...Tosoh Bioscience IncCDZ
Z-2652-2026Class IIIngenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity...Philips North America LLCJAK
Z-2651-2026Class IIIQon Spectral CT IQon Spectral CT UpgradesPhilips North America LLCJAK
Z-2650-2026Class IIBrilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64...Philips North America LLCJAK
Z-2791-2026Class IIMedline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2790-2026Class IIMedline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397PMEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2789-2026Class IIMedline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2788-2026Class IIMedline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2857-2026Class IIBrand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog...Oxos Medical IncOWB
Z-2757-2026Class IIFARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and...Boston Scientific CorporationDRA
Z-2756-2026Class IIFARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and...Boston Scientific CorporationDRA
Z-2755-2026Class IIFARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into...Boston Scientific CorporationDRA
Z-2754-2026Class IIFARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and...Boston Scientific CorporationDRA
Z-2753-2026Class IIFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401...Boston Scientific CorporationQZI