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 347 of 1190
FDA device recalls, page 347 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2190-2020Class IIOSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The...OsteomedMQV
Z-2189-2020Class IIOSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage...OsteomedMQV
Z-2188-2020Class IIOSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The...OsteomedMQV
Z-2187-2020Class IIOSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The...OsteomedMQV
Z-2165-2020Class IIOmnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011...Insulet CorporationLZG
Z-2164-2020Class IIOmnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010...Insulet CorporationLZG
Z-2111-2020Class IIGiraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN...GE HealthcareFMZ
Z-2186-2020Class IIOSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The...OsteomedMQV
Z-2185-2020Class IIOSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The...OsteomedMQV
Z-2184-2020Class IIOSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The...OsteomedMQV
Z-2183-2020Class IIOSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The...OsteomedMQV
Z-2182-2020Class IIOSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The...OsteomedMQV
Z-2181-2020Class IIOSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The...OsteomedMQV
Z-2180-2020Class IIOSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The...OsteomedMQV
Z-2251-2020Class IIAccelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS...Abbott MedicalCEM
Z-1482-2022Class IIPRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product...Aesculap IncKOA
Z-1481-2022Class IIPRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product...Aesculap IncKOA
Z-1895-2020Class IIIARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and...Abbott MedicalJKD
Z-1894-2020Class IIIARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and...Abbott MedicalJJX
Z-1931-2020Class IIVITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90...Ortho-Clinical Diagnostics, Inc.JHS
Z-1900-2020Class IICortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010Howmedica Osteonics CorpNDN
Z-1893-2020Class IIIARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and...Abbott MedicalJIT
Z-1930-2020Class IIVITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300...Ortho-Clinical Diagnostics, Inc.JHS
Z-2143-2020Class IIBridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire...Spectranetics Corp.MJN
Z-1971-2020Class IIAnalyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01...Becton, Dickinson and Company, BD BiosciencesMVU
Z-1945-2020Class IIiQ200 Series Urine Microscopy Analyzer- All part numbersSiemens Healthcare Diagnostics Inc.KQO
Z-1944-2020Class IIiChemVELOCITY Urine Chemistry System-Siemens Healthcare Diagnostics Inc.KQO
Z-1798-2020Class IIMoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for...Boston Scientific CorporationGEX
Z-1826-2020Class IILeksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc...Elekta LimitedHAW
Z-2007-2020Class IISterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/...Edwards Lifesciences LLCDQE
Z-2113-2020Class IICardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical...Stryker Sustainability SolutionsOWQ
Z-2819-2020Class IIPositron Emission Tomography and Computed Tomography System, Model: uMI 550, Material...Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-1941-2020Class IIVERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628Medtronic Sofamor Danek USA IncKWP
Z-1807-2020Class IINeptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The...Stryker Corp.GEI
Z-1795-2020Class IICareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only...Becton Dickinson & CoGCB
Z-1910-2020Class IIGentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey...GentellFRO
Z-1909-2020Class IIGentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing...GentellFRO
Z-1908-2020Class IIGentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing...GentellFRO
Z-1907-2020Class IIGentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing...GentellFRO
Z-2370-2020Class IIXience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100...Abbott VascularNIQ
Z-0107-2022Class ICADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b...Abbott MedicalFRN
Z-0509-2021Class IIB. Braun Introcan Safety IV Catheters, Product codes REF...Janus Trade GroupFOZ
Z-2299-2020Class IITriever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration...Inari Medical, Inc.DXE
Z-1966-2020Class IIRapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of...Magstim Inc.OBP
Z-1965-2020Class IIHorizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the...Magstim Inc.OBP
Z-2192-2020Class IIPower supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557...Abbott Diagnostics Technologies ASPDJ
Z-1763-2020Class IIOlympus Pleuravideoscope, Model LTF-240OLYMPUS Corporation of the AmericasGCJ
Z-1762-2020Class IIOlympus Pleuravideoscope, Model LTF-160OLYMPUS Corporation of the AmericasGCJ
Z-1567-2020Class ILeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84...LeMaitre Vascular Inc.DXE
Z-2407-2020Class IIIUtak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label...Utak Laboratories IncJJY