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

59,460 records, page 142 of 1190
FDA device recalls, page 142 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1940-2024Class IIThe Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and...Stryker Corp.MOF
Z-1939-2024Class IIThe Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The...Stryker Corp.DQX
Z-2158-2024Class IIOPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b)...Exactech, Inc.JWH
Z-2157-2024Class IIOPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c)...Exactech, Inc.JWH
Z-2156-2024Class IIOPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM...Exactech, Inc.JWH
Z-2155-2024Class IIOPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM...Exactech, Inc.JWH
Z-2356-2024Class IIMi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28...Med-el Elektromedizinische Geraete, GmbHMCM
Z-2264-2024Class IIDxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnosticSiemens Healthcare Diagnostics Inc.JJE
Z-1811-2024Class IOptum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion PumpOptum Distribution Center, LLCFRN
Z-1944-2024Class IIAlaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y...BD Switzerland SARLFPA
Z-1890-2024Class IIVercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT...Boston Scientific Neuromodulation CorporationNHL
Z-1870-2024Class II2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1869-2024Class II2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1868-2024Class II2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1867-2024Class II2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1816-2024Class IIOptical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2)...Yamaha Motor Co LtdRGA
Z-1815-2024Class IIYamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M...Yamaha Motor Co LtdRGA
Z-1936-2024Class IISyringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2...MEDLINE INDUSTRIES, LP - NorthfieldFMF
Z-1866-2024Class IIBlood Pump Rotor, Model Number: F40015481 Rev AFresenius Medical Care Renal Therapies Group, LLCKDI
Z-1824-2024Class IISyntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and...LeMaitre Vascular Inc.DXE
Z-1873-2024Class IIIntegra Cranial access kit (without Prep solutions) Bit and Guard- Used during a...Integra LifeSciences CorporationHBG
Z-1835-2024Class IICardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm)...Medtronic, Inc.KGX
Z-1784-2024Class IIIntelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop...NRT X-Ray a/SOWB
Z-2212-2024Class IIProduct not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA...Medtronic, Inc.LWS
Z-2211-2024Class IICROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2210-2024Class IICOBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2209-2024Class IICobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2208-2024Class IICOBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2207-2024Class IICOBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2206-2024Class IICOBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2205-2024Class IIMIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2204-2024Class IIMIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2203-2024Class IIPRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2202-2024Class IIMIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2201-2024Class IIMIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2200-2024Class IIPRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2199-2024Class IIEVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2198-2024Class IIEVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2197-2024Class IIEVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2196-2024Class IIEVERA S VR, Model Number DVBC3D1, Implantable Cardioverter DefibrillatorMedtronic, Inc.LWS
Z-2195-2024Class IICROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter...Medtronic, Inc.NIK
Z-2194-2024Class IICOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter...Medtronic, Inc.NIK
Z-2193-2024Class IICOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter...Medtronic, Inc.NIK
Z-2192-2024Class IICobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter...Medtronic, Inc.NIK
Z-2191-2024Class IICOBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter...Medtronic, Inc.NIK
Z-2190-2024Class IICOBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter...Medtronic, Inc.NIK
Z-1933-2024Class IIRefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation...Reflexion Medical, Inc.QVA
Z-1883-2024Class IIStryker Blueprint Software, Catalog #BPUE001.Tornier S.A.S.PHX
Z-2040-2024Class IIMyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and...GE Medical Systems Israel, Functional ImagingKPS
Z-1872-2024Class IIIncisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images...Philips North America LLCJAK