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 107 of 1190
FDA device recalls, page 107 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0662-2025Class IExacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH...Medtronic NeurosurgeryGWM
Z-0661-2025Class IBecker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120...Medtronic NeurosurgeryGWM
Z-0675-2025Class IICardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product...Medtronic, Inc.FYC
Z-0674-2025Class IIConvertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL...Medtronic, Inc.FYC
Z-0522-2025Class IIKreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts...Kreatech Biotechnology BVMVU
Z-0570-2025Class IIArial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the...Securitas Healthcare LLCIQA
Z-0582-2025Class IICook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.Wilson-Cook Medical Inc.QAU
Z-0678-2025Class IIHybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software...Hermes Medical Solutions ABKPS
Z-0598-2025Class IICartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm)...Cartiva, Inc.PNW
Z-0620-2025Class IIEVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190OLYMPUS Corporation of the AmericasFDS
Z-0596-2025Class IIBACTEC 9240 System Version or Model: 445475 Catalog Number: 445475Becton Dickinson & CoMDB
Z-0595-2025Class IIBACTEC 9120 System Version or Model: 445570 Catalog Number: 445570Becton Dickinson & CoMDB
Z-0594-2025Class IIBD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296Becton Dickinson & CoMDB
Z-0593-2025Class IIBD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385Becton Dickinson & CoMDB
Z-0592-2025Class IIBD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number...Becton Dickinson & CoLON
Z-0591-2025Class IIBD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog...Becton Dickinson & CoJQP
Z-0590-2025Class IIBD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916Becton Dickinson & CoOZN
Z-0589-2025Class IIBD COR GX Instrument Version or Model: 443990 Catalog Number: 443990Becton Dickinson & CoQEP
Z-0588-2025Class IIBD COR MX Instrument Version or Model: 443989 Catalog Number: 443989Becton Dickinson & CoQEP
Z-0587-2025Class IIBD COR PX Instrument Version or Model: 443988 Catalog Number: 443988Becton Dickinson & CoMAQ
Z-0586-2025Class IIBD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog...Becton Dickinson & CoJQP
Z-0585-2025Class IIBD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887Becton Dickinson & CoJQP
Z-0584-2025Class IIBD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007Becton Dickinson & CoJQP
Z-0549-2025Class IIOffset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and...Incipio DevicesHWA
Z-0752-2025Class IIBrand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature...SeaSpine Orthopedics CorporationNKB
Z-0751-2025Class IIBrand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature...SeaSpine Orthopedics CorporationNKB
Z-0699-2025Class IIEVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF...Microport Orthopedics Inc.MBH
Z-0581-2025Class IIBIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.Smith & Nephew, Inc.MBI
Z-0520-2025Class IITomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic...GE HealthcareLNH
Z-0519-2025Class IISIGNA Architect AIR, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-0518-2025Class IISIGNA Architect, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-0517-2025Class IIDiscovery MR750w 3.0T, whole body magnetic resonance scannerGE HealthcareLNH
Z-0557-2025Class IIITempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator...Remote Diagnostic Technologies Ltd.LDD
Z-0531-2025Class IIAMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OBoston Scientific CorporationEZY
Z-0530-2025Class IIAMS Artificial Urinary Sphincter Control PumpBoston Scientific CorporationEZY
Z-0529-2025Class IIsmiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76Abbott MedicalBSR
Z-0528-2025Class IIsmiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF...Abbott MedicalBSR
Z-0527-2025Class IIsmiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17...Abbott MedicalBSR
Z-0742-2025Class IIGalaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to...NOAH MEDICAL Corp.EOQ
Z-0693-2025Class IIGalaxy System (GAL-001)NOAH MEDICAL Corp.EOQ
Z-0558-2025Class IIENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0679-2025Class IIGalaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752...NOAH MEDICAL Corp.EOQ
Z-0550-2025Class IIGE Proteus XR/A radiographic systemGE Healthcare (China) Co., Ltd.KPR
Z-0361-2025Class IIURINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0360-2025Class IIURINE KIT, SKU DYKM1845; Component No. 503581MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0359-2025Class IIURINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0358-2025Class IIURINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0357-2025Class IIURINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0356-2025Class IIUA KIT, SKU DYKM1690A; Component No. 503581MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0355-2025Class IILab Kit, SKU DYLAB1018; Component No. 503581MEDLINE INDUSTRIES, LP - NorthfieldLRO