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 118 of 1190
FDA device recalls, page 118 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3153-2024Class IIvenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and...Fresenius Kabi USA, LLCFRN
Z-0039-2025Class IIGE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code...GE HealthcareLLZ
Z-0036-2025Class IICook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and...Wilson-Cook Medical Inc.QAU
Z-3311-2024Class IIBiofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of...CooperVision, Inc.LPM
Z-3310-2024Class IIBIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia...CooperVision, Inc.LPM
Z-3155-2024Class IIstryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A...TORNIER Inc.PKC
Z-3309-2024Class IIStryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder...TORNIER Inc.PAO
Z-3209-2024Class IIGood Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning...MicroCare MedicalJCB
Z-0124-2025Class IIMedline Open Heart Nimc Kit, Ref Dynj908840MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0123-2025Class IIMedline Kit Cv I II, Ref Dynj906071bMEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0122-2025Class IIMedline Open Heart, Ref Dynj904261bMEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0121-2025Class IIMedline Open Heart Pack, Ref Dynj66216cMEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0120-2025Class IIMedline Heart Overhead Table Pack, Ref Dynj0778508jMEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0119-2025Class IIMedline Heart Cabg Cds, Ref Cds983376rMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0053-2025Class IIMedline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0094-2025Class IIThe Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay...Siemens Healthcare Diagnostics Inc.JLW
Z-3183-2024Class IIKits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK...Safeguard US Operating LLCIMD
Z-3182-2024Class IIHAWK Advanced Hypothermia Management Set, Item Number: 59-320Safeguard US Operating LLCIMD
Z-3181-2024Class IIHAWK Warming Grid, Item Number: 59-300Safeguard US Operating LLCIMD
Z-0131-2025Class IIBrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number...Nova Ortho-Med IncITJ
Z-0130-2025Class IIBrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog...Nova Ortho-Med IncITJ
Z-0129-2025Class IIBrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number...Nova Ortho-Med IncITJ
Z-0022-2025Class IIFastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP...Qualigen IncJLW
Z-0556-2025Class IIDiode Laser Hair Removal model: WLA-01Wingderm Electro-Optics Ltd.GEX
Z-0555-2025Class IINon-ablative Fractional Laser Systems, Model: WFB-01Wingderm Electro-Optics Ltd.ONG
Z-0229-2025Class IIOlympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)OLYMPUS Corporation of the AmericasFEQ
Z-0259-2025Class IIOsom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human...Princeton BioMeditech Corp.JHI
Z-0008-2025Class IIBIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl...Young Dental Manufacturing Co 1, LLC.FLG
Z-3210-2024Class IIAVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated...Howmedica Osteonics CorpOVE
Z-3168-2024Class IISystem Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva...Philips Medical Systems Nederland B.V.KPR
Z-3167-2024Class IISystem Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV...Philips Medical Systems Nederland B.V.OWB
Z-3166-2024Class IISystem Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura...Philips Medical Systems Nederland B.V.OWB
Z-0050-2025Class IIStealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation...Medtronic Navigation, IncOLO
Z-3165-2024Class IISystem Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235...Philips Medical Systems Nederland B.V.OWB
Z-3303-2024Class IIHealgen Series Reagent strips for Urinalysis are composed of several color pads aligned...Healgen Scientific LLCJIR
Z-0049-2025Class IKINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ...KinovaIQZ
Z-0964-2026Class IIda Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part...Intuitive Surgical, Inc.NAY
Z-0181-2025Class IIOlympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100OLYMPUS Corporation of the AmericasFET
Z-0125-2025Class IICortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045Xtant Medical Holdings, Inc.NKB
Z-0128-2025Class IIMcKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.Change Healthcare Canada CompanyDQK
Z-0127-2025Class IIHorizon Cardiology Hemo. Version 12.2.Change Healthcare Canada CompanyDQK
Z-0126-2025Class IIChange Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3...Change Healthcare Canada CompanyMWI
Z-0132-2025Class IIVanta Implantable Neurostimulator (INS), Model 977006Medtronic NeuromodulationLGW
Z-3305-2024Class IIAtellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)Siemens Healthcare Diagnostics Inc.JZO
Z-3304-2024Class IIADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)Siemens Healthcare Diagnostics Inc.JZO
Z-3208-2024Class IPercussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive...Percussionaire Corp.BZO
Z-3207-2024Class IPercussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive...Percussionaire Corp.BZO
Z-0006-2025Class IIMiami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101Ossur Iceland ehf.IQK
Z-3185-2024Class IIAcceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008Cypress Medical Products LLCGTY
Z-3184-2024Class IIBinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025Cypress Medical Products LLCGTZ