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 120 of 1190
FDA device recalls, page 120 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1292-2025Class IIVios Monitoring System Bedside Monitor Model BSM2050Murata Vios, Inc.DRT
Z-0142-2025Class IISTERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL...Physio Control, Inc.LDD
Z-3081-2024Class IIGE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2)...Wipro GE Healthcare Private Ltd.FMT
Z-3080-2024Class IIGE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide...Wipro GE Healthcare Private Ltd.FMT
Z-0524-2025Class IIFusion Pro 24, Model 17000Epilog Laser Corp.RHK
Z-0579-2025Class IIZiehm Vision RFD 3D. Interventinoal fluoroscopic x-ray systemOrthoscan, Inc.OWB
Z-0578-2025Class IIZiehm Vision RFD. Interventional fluoroscopic x-ray systemOrthoscan, Inc.OWB
Z-0577-2025Class IIZiehm Vision R. Iterventional fluoroscopic x-ray systemOrthoscan, Inc.OWB
Z-0576-2025Class IIZiehm Vision FD. Interventional fluoroscopic x-ray systemOrthoscan, Inc.OWB
Z-0575-2025Class IIZiehm Vision system, x-ray, tomography, computed.Orthoscan, Inc.JAK
Z-0574-2025Class IIZiehm Solo FD. Interventional fluoroscopic x-ray systemOrthoscan, Inc.OWB
Z-0573-2025Class IIZiehm Solo. Digital Mobile C-armOrthoscan, Inc.OWB
Z-3313-2024Class IIDAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,Alcon LaboratoriesLPL
Z-3263-2024Class IIIeakin Cohesive seal, small, Model Number 839002, ostomy barrier sealT.G. Eakin, Ltd.EXE
Z-3133-2024Class IIBiolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip...Zimmer GmbHLZO
Z-3132-2024Class IIBiolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip...Zimmer GmbHLZO
Z-3124-2024Class IIBlood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-3137-2024Class ICARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to...Datascope Corp.DSP
Z-3136-2024Class ICARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to...Datascope Corp.DSP
Z-3146-2024Class IIViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e)...GE HealthcareLLZ
Z-3145-2024Class IIViewPoint; system, imaging processing, radiologicalGE HealthcareLLZ
Z-3144-2024Class IIAET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way...B Braun Medical IncFPA
Z-3135-2024Class ICARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to...Datascope Corp.DSP
Z-3134-2024Class ICARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to...Datascope Corp.DSP
Z-2716-2024Class IIPhilips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray...Philips Medical Systems Nederland B.V.OWB
Z-0044-2025Class IIMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063Howmedica Osteonics CorpOLO
Z-3244-2024Class IIPacemaker, COPM11B; Medical convenience kitAmerican Contract Systems, Inc.OEZ
Z-3243-2024Class IICysto, FTCY03L; Medical convenience kitAmerican Contract Systems, Inc.NWU
Z-3242-2024Class IINasal Sinus Pack, MTSN26B; Medical convenience kitAmerican Contract Systems, Inc.OGR
Z-3241-2024Class IIENT, COEN27N; Medical convenience kitAmerican Contract Systems, Inc.OGR
Z-3240-2024Class IIEssentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kitAmerican Contract Systems, Inc.FDE
Z-3239-2024Class IICath Lab Pack, CECL02P; Medical convenience kitAmerican Contract Systems, Inc.OES
Z-3238-2024Class IIVaginal Delivery, ASDV25B; Medical convenience kitAmerican Contract Systems, Inc.MLS
Z-3237-2024Class IIHand Pack, AKHD97C; Medical convenience kitAmerican Contract Systems, Inc.OJH
Z-3236-2024Class IINeuro Vascular, ANKV91A; Medical convenience kitAmerican Contract Systems, Inc.OJG
Z-3235-2024Class IIIR Procedure Pack, CEAT19W; Medical convenience kitAmerican Contract Systems, Inc.OEQ
Z-3234-2024Class IIParacentesis Thoracente, SLPT76H; Medical convenience kitAmerican Contract Systems, Inc.OEZ
Z-3233-2024Class IIBilateral Tubal Ligation Pack, FHBT3T; Medical convenience kitAmerican Contract Systems, Inc.OHD
Z-3232-2024Class IIShoulder, SESH18I; Medical convenience kitAmerican Contract Systems, Inc.OJH
Z-3231-2024Class IIDay Surgery General Pack, FHGE18T; Medical convenience kitAmerican Contract Systems, Inc.LRO
Z-3230-2024Class IIOpen Shoulder, LWOS39L; Medical convenience kitAmerican Contract Systems, Inc.OJH
Z-3229-2024Class IIArthroscopy Pack, MSKA45A; Medical convenience kitAmerican Contract Systems, Inc.OJH
Z-3228-2024Class IIEndovascular AAA Pack, ESED52B; Medical convenience kitAmerican Contract Systems, Inc.MLS
Z-3227-2024Class IIEndovascular AAA Pack, ESED52B; Medical convenience kitAmerican Contract Systems, Inc.OEZ
Z-3226-2024Class IIPACEMAKER PACK, SLCV01J; Medical convenience kitAmerican Contract Systems, Inc.OEZ
Z-3262-2024Class IIPT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The...Fisher & Paykel Healthcare, Inc.QAV
Z-3261-2024Class IIBiodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal...Cook Biotech, Inc.FTM
Z-3260-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue...Cook Biotech, Inc.FTM
Z-3259-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue...Cook Biotech, Inc.FTM
Z-3258-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue...Cook Biotech, Inc.FTM