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 102 of 1190
FDA device recalls, page 102 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0944-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM...Sklar CorporationHDF
Z-0943-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE...Sklar CorporationHCY
Z-0942-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER...Sklar CorporationMDM
Z-0941-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD...Sklar CorporationLRW
Z-0940-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD...Sklar CorporationHTD
Z-0939-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD...Sklar CorporationGEN
Z-0938-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE...Sklar CorporationGEA
Z-0937-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC...Sklar CorporationGDZ
Z-0936-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER...Sklar CorporationGDJ
Z-0935-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM...Sklar CorporationGDG
Z-0934-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL...Sklar CorporationGAF
Z-0933-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2)...Sklar CorporationGAD
Z-0932-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75"...Sklar CorporationFZT
Z-0931-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL...Sklar CorporationFZS
Z-0930-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD...Sklar CorporationEPY
Z-0929-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3...Sklar CorporationFFO
Z-0928-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD...Sklar CorporationFBX
Z-0927-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25...Sklar CorporationKCG
Z-0926-2025Class IIECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE...Sklar CorporationKAD
Z-0925-2025Class IIECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR...Sklar CorporationJYG
Z-1118-2025Class IIUNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code...Medicrea InternationalLLZ
Z-0807-2025Class II100V Neptune 3 Rover Japanese (0703-003-000) 120V Neptune S Rover (0711-001-000) 230V...Stryker Corp.GEI
Z-0805-2025Class IIIThe FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the...Qualigen IncCDZ
Z-0959-2025Class IIChange Healthcare Cardiology Hemodynamics softwareA L I Technologies LtdMWI
Z-0958-2025Class IIChange Healthcare Cardiology Hemo softwareA L I Technologies LtdMWI
Z-0957-2025Class IIMcKesson Cardiology Hemo softwareA L I Technologies LtdMWI
Z-0961-2025Class IIVerifyNow P2Y12 Platelet Reactivity Test, REF: 85064Accriva Diagnostics, Inc.JOZ
Z-0990-2025Class IIMicrovention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF...Terumo Cardiovascular Systems CorporationDQY
Z-0845-2025Class IIX-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120...MEDLINE INDUSTRIES, LP - NorthfieldEZL
Z-0844-2025Class IIFolysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110...MEDLINE INDUSTRIES, LP - NorthfieldEZL
Z-0762-2025Class IIMISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small...Moximed, Inc.QVV
Z-0903-2025Class IIEsteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece...ConvaTec LimitedEXE
Z-0955-2025Class IIOsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100...IsoTis OrthoBiologics, Inc.MQV
Z-0919-2025Class IIOsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.IsoTis OrthoBiologics, Inc.MQV
Z-0828-2025Class IIBrand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model /...3B Medical IncBZB
Z-0716-2025Class ISheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access...Trokamed GmbHFED
Z-0715-2025Class ISheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access...Trokamed GmbHFED
Z-0714-2025Class ISheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access...Trokamed GmbHFED
Z-0713-2025Class ISheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access...Trokamed GmbHFED
Z-0983-2025Class IIBrand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software...O&M Halyard, Inc.KKX
Z-0819-2025Class IIAMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog...Applied Medical Technology IncPIF
Z-0803-2025Class IIAccess Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the...Siemens Healthcare Diagnostics Inc.CEW
Z-0797-2025Class II3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit...3M UNITEK CorporationKLE
Z-1003-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-1002-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-0813-2025Class IIGE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1)...GE HealthcareIZL
Z-0812-2025Class IIGE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1)...GE HealthcareIZL
Z-0811-2025Class IIGE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1)...GE HealthcareIZL
Z-1001-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL
Z-1000-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name...OLYMPUS Corporation of the AmericasLFL