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 388 of 1190
FDA device recalls, page 388 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0407-2020Class IIEPISTAXIS TRAY Kit Code: MNS10165Centurion Medical Products, LPOGR
Z-2084-2019Class IIRX Imola, Model Nos. RX4900Randox Laboratories, LimitedJJE
Z-2083-2019Class IIRX Daytona, Model Nos. RX4040 and RX4041Randox Laboratories, LimitedJJE
Z-1976-2019Class IIITAPSYSTEM Model 2A, REF 8002ACardiocommand Inc.LPA
Z-1980-2019Class IIElekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic...Elekta LimitedIYE
Z-2065-2019Class IVigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product...Fenwal IncPHC
Z-2064-2019Class IVOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product...Fenwal IncFRN
Z-2098-2019Class IIA&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode...Alto Development CorpLDF
Z-2356-2019Class IINorm-O-Temp model 111WGentherm Medical, LLCDWJ
Z-2355-2019Class IINorm-O-Temp model 111ZGentherm Medical, LLCDWJ
Z-1954-2019Class IICios care fusion systemSiemens Medical Solutions USA, Inc.OWB
Z-1953-2019Class IICios Alpha VA20/ VA30 mobile X-Ray systemsSiemens Medical Solutions USA, Inc.OWB
Z-2075-2019Class IELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI...Abbott MedicalLWS
Z-2074-2019Class IELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI...Abbott MedicalLWS
Z-2073-2019Class IELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)Abbott MedicalLWS
Z-2072-2019Class IELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI...Abbott MedicalLWS
Z-2071-2019Class IELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)Abbott MedicalLWS
Z-2070-2019Class IELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)Abbott MedicalLWS
Z-1429-2020Class IISeca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009SecaFRW
Z-0184-2020Class IISterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or...Andover Healthcare Inc.FQM
Z-0183-2020Class IISterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or...Andover Healthcare Inc.FQM
Z-0182-2020Class IISterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or...Andover Healthcare Inc.FQM
Z-0181-2020Class IISterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or...Andover Healthcare Inc.FQM
Z-0180-2020Class IISterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression...Andover Healthcare Inc.FQM
Z-0179-2020Class IISterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression...Andover Healthcare Inc.FQM
Z-2230-2019Class IIiGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2Elekta LimitedIYE
Z-1972-2019Class IIAlpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode...Pharmaceutical Innovations, Inc.GYB
Z-1971-2019Class IIElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray...Pharmaceutical Innovations, Inc.GYB
Z-1970-2019Class IIElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray...Pharmaceutical Innovations, Inc.GYB
Z-1969-2019Class IIElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray...Pharmaceutical Innovations, Inc.GYB
Z-1968-2019Class IIAlpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode...Pharmaceutical Innovations, Inc.GYB
Z-2160-2019Class IISerrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm...Howmedica Osteonics CorpNKB
Z-2204-2019Class IILSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt...AD-Tech Medical Instrument Corp.GZL
Z-2069-2019Class IIVersa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile...Epimed International, Inc.BSO
Z-2068-2019Class IIVersa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile...Epimed International, Inc.BSO
Z-2408-2019Class IISkull Anchor BoltsAD-Tech Medical Instrument Corp.GZL
Z-2407-2019Class IIDepth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer...AD-Tech Medical Instrument Corp.GZL
Z-2406-2019Class IIDual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural ElectrodesAD-Tech Medical Instrument Corp.GYC
Z-1981-2019Class IIDeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical packDeRoyal Industries, Inc.LRO
Z-2057-2019Class IILEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 &...CooperSurgical, Inc.HGI
Z-0283-2021Class IIda Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI...Intuitive Surgical, Inc.NAY
Z-2202-2019Class IIVITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products...Ortho-Clinical Diagnostics, Inc.CGA
Z-1944-2019Class ICS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.Datascope Corp.DSP
Z-1943-2019Class ICS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.Datascope Corp.DSP
Z-1942-2019Class ICS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.Datascope Corp.DSP
Z-1941-2019Class ICS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.Datascope Corp.DSP
Z-1940-2019Class ICardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.Datascope Corp.DSP
Z-1939-2019Class ICardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular...Datascope Corp.DSP
Z-2209-2020Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16FBard Peripheral Vascular IncMSD
Z-2208-2020Class IIEQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16FBard Peripheral Vascular IncMSD