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 40 of 1187
FDA device recalls, page 40 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1242-2026Class IINAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1241-2026Class IINAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1240-2026Class IINAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1239-2026Class IISOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1163-2026Class I*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material...Boston Scientific CorporationKNS
Z-1162-2026Class I*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1161-2026Class IHOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1160-2026Class IAXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1159-2026Class IAXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1158-2026Class IAXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number...Boston Scientific CorporationKNS
Z-1133-2026Class IIBrand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog...Microport Orthopedics Inc.N/A
Z-1132-2026Class IIBrand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate...Tyber MedicalHRS
Z-1131-2026Class IIBrand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate...Tyber MedicalHRS
Z-1101-2026Class IIPortex Spinal Tray, Item No. A3729-24 A3595Abbott MedicalCAZ
Z-1100-2026Class IIPulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PGAbbott MedicalJKA
Z-1111-2026Class IITego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000Abbott MedicalFPA
Z-1237-2026Class IITORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318TORNIER Inc.KWS
Z-1018-2026Class IIVANTAGE TITAN 3T Model MRT-3010/MEXL-3010Canon Medical Systems USA, Inc.LNH
Z-1017-2026Class IIVANTAGE GALAN 3T Model MRT-3020/MEXL-3020Canon Medical Systems USA, Inc.LNH
Z-1179-2026Class IIAlphenix INFX-8000V, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1178-2026Class IIAlphenix INFX-8000H, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1177-2026Class IIAlphenix INFX-8000F, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1176-2026Class IIAlphenix INFX-8000C, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1492-2026Class IIGelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE...Vascutek, Ltd.DSY
Z-1362-2026Class IITeslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code...Wilson-Cook Medical Inc.KNS
Z-1139-2026Class IIRifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training...Community Products, LLCFSA
Z-1138-2026Class IIRifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift...Community Products, LLCFSA
Z-1137-2026Class IIRifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device...Community Products, LLCFSA
Z-1173-2026Class IIAlternatiV+ Screw-In AnchorAju Medical Co., Ltd.MAI
Z-1172-2026Class IIAlternatiV+ Max Knotless AnchorAju Medical Co., Ltd.MAI
Z-1171-2026Class IIGenesis Push-In Suture AnchorAju Medical Co., Ltd.MAI
Z-1170-2026Class IIGenesis Knotless AnchorAju Medical Co., Ltd.MAI
Z-1169-2026Class IIGenesis Dual Thread Screw-In AnchorAju Medical Co., Ltd.MAI
Z-1168-2026Class IIGenesis Screw-In AnchorAju Medical Co., Ltd.MAI
Z-1167-2026Class IIFixone Biocomposite AnchorAju Medical Co., Ltd.MAI
Z-1166-2026Class IIFixone Hybrid AnchorAju Medical Co., Ltd.MAI
Z-1256-2026Class IIVortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral MarkerVortex Surgical, Inc.HMQ
Z-1255-2026Class IIVortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27Vortex Surgical, Inc.MXY
Z-1254-2026Class IIVortex Surgical TID Pharos Illuminated Depressor, VS0801BVortex Surgical, Inc.HJM
Z-1253-2026Class IIRumex Disposable Diamond Dusted ILM Elevator, 12-7523Vortex Surgical, Inc.HNQ
Z-1252-2026Class IIVortex Surgical I2 Injection Kit, VS0500Vortex Surgical, Inc.KDD
Z-1251-2026Class IITecfen Retractable Membrane Polisher, QTPR1267-23Vortex Surgical, Inc.HNQ
Z-1250-2026Class IIVortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25Vortex Surgical, Inc.MXY
Z-1249-2026Class IIConvenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit...Vortex Surgical, Inc.KDD
Z-1248-2026Class II25GA Subretinal Injection Cannula VS0220.25Vortex Surgical, Inc.MXY
Z-1247-2026Class IIVortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA...Vortex Surgical, Inc.HNR
Z-1246-2026Class IIOertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated...Vortex Surgical, Inc.HQB
Z-1245-2026Class IIVortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe...Vortex Surgical, Inc.HQB
Z-1244-2026Class IIVolk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk...Vortex Surgical, Inc.HJK
Z-1090-2026Class IIMedline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE...MEDLINE INDUSTRIES, LP - NorthfieldOKV