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All years

Medical device recalls reported in 2017

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ReportedRecallClassProductFirm
2017-05-10Z-2009-2017Class IIMinimal Access Attachment Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2010-2017Class IIMinimal Access AttachmentThe Anspach Effort, Inc.
2017-05-10Z-2011-2017Class IIMinimal Access Straight Driver Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2012-2017Class II8The Anspach Effort, Inc.
2017-05-10Z-2013-2017Class II8The Anspach Effort, Inc.
2017-05-10Z-2014-2017Class II16cm Minimally Invasive Attachment Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2015-2017Class IISagittal Saw Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2016-2017Class IIOtologic Curved Micro Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2017-2017Class II45 degree Contra Angle Attachment Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2018-2017Class II90 degree Contra Angle Attachment Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2019-2017Class IIOscillating MICRO-SAW Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2020-2017Class II11cm QD Angle Attachment Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2021-2017Class II10The Anspach Effort, Inc.
2017-05-10Z-2022-2017Class II14cm QD Angle Attachment Product Usage: Pneumatic systemThe Anspach Effort, Inc.
2017-05-10Z-2023-2017Class II14cm QD Angle AttachmentThe Anspach Effort, Inc.
2017-05-10Z-2024-2017Class II8cm QD Angle AttachmentThe Anspach Effort, Inc.
2017-05-10Z-2025-2017Class II7The Anspach Effort, Inc.
2017-05-10Z-2026-2017Class IIReciprocating MICRO SAWThe Anspach Effort, Inc.
2017-05-10Z-2027-2017Class IISMALL ATTACHMENTThe Anspach Effort, Inc.
2017-05-10Z-2028-2017Class IISMALL ATTACHMENTThe Anspach Effort, Inc.
2017-05-10Z-2029-2017Class II5The Anspach Effort, Inc.
2017-05-10Z-2030-2017Class II5The Anspach Effort, Inc.
2017-05-10Z-2031-2017Class IISagittal MICRO-SAWThe Anspach Effort, Inc.
2017-05-10Z-2032-2017Class II20The Anspach Effort, Inc.
2017-05-10Z-2033-2017Class IIDestination Renal Guiding Sheath Intended for the introduction of…Terumo Medical Corporation
2017-05-10Z-2034-2017Class IISysmexSysmex America Inc
2017-05-10Z-2035-2017Class IIAQUIOS CL Flow CytometerBeckman Coulter Inc.
2017-05-03Z-1538-2017Class IHeartWare HVAD System Controller The HeartWare Ventricular Assist…Heartware
2017-05-03Z-1832-2017Class IHeartWare Ventricular Assist SystemHeartware
2017-05-03Z-1875-2017Class II18L6 HD transducer on the ACUSON S Family ultrasound systems with…Siemens Medical Solutions USA, Inc.
2017-05-03Z-1876-2017Class IIIBBL Trypticase Soy Agar with 5% Sheep BloodBecton Dickinson & Co.
2017-05-03Z-1877-2017Class IIViperWire Advance with Flextip Peripheral Atherectomy Guide WireCardiovascular Systems Inc
2017-05-03Z-1878-2017Class IIuNion Cervical Plate System Product Usage: The uNion Cervical Plate…Ulrich Medical USA Inc
2017-05-03Z-1879-2017Class IIPressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous…Arrow International Inc
2017-05-03Z-1880-2017Class IIOmega Incline Platform LiftSavaria Concord Lifts, Inc.
2017-05-03Z-1881-2017Class IINavitrack SystemOrthosoft, Inc. dba Zimmer CAS
2017-05-03Z-1882-2017Class IIThe Savaria Stairfriend is a ResidentialSavaria Concord Lifts, Inc.
2017-05-03Z-1883-2017Class IISmartSite Add-On Bag Access DeviceCareFusion 303, Inc.
2017-05-03Z-1884-2017Class II5XTANT MEDICAL INC
2017-05-03Z-1885-2017Class II01Amendia, Inc
2017-05-03Z-1886-2017Class IIStryker SmartLife Large Aseptic HousingStryker Instruments Div. of Stryker Corporation
2017-05-03Z-1887-2017Class IIVITROS Chemistry Products VANC ReagentOrtho-Clinical Diagnostics
2017-05-03Z-1888-2017Class IIBlood AgarRemel Inc
2017-05-03Z-1889-2017Class II1 mL Medallion¿ SyringeMerit Medical Systems, Inc.
2017-04-26Z-1820-2017Class IIAllura Xper Release 8Philips Electronics North America Corporation
2017-04-26Z-1821-2017Class IIUNIQ: UNIQ FD10 722026Philips Electronics North America Corporation
2017-04-26Z-1822-2017Class IIThe following systems are only affected if a Laird chiller is…Philips Electronics North America Corporation
2017-04-26Z-1823-2017Class IITapered SwissPlus Implant SystemZimmer Dental Inc
2017-04-26Z-1824-2017Class IIArtis zeeSiemens Medical Solutions USA, Inc
2017-04-26Z-1825-2017Class IIHemotherm CECincinnati Sub-Zero Products Inc
2017-04-26Z-1826-2017Class IICordis SCordis Corporation
2017-04-26Z-1827-2017Class IIFerno PROFlexx¿ Model 28Z Chair CotFerno-Washington Inc
2017-04-26Z-1828-2017Class IIMerge Eye Station and Merge Eye Care PACSMerge Healthcare, Inc.
2017-04-26Z-1829-2017Class IIIArrow EZ-IO Needle Set 45 mm 15 gaTeleflex Medical
2017-04-26Z-1830-2017Class IIProteus 235Ion Beam Applications S.A.
2017-04-26Z-1831-2017Class IINEODENT CM Intraoral ScanbodyInstradent USA, Inc.
2017-04-26Z-1833-2017Class IIAccess Ferritin CalibratorsBeckman Coulter Inc.
2017-04-26Z-1834-2017Class IISoft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090Signal Medical Corporation
2017-04-26Z-1835-2017Class IIINFINITY Internal Hex Healing AbutmentAce Surgical Supply Co., Inc.
2017-04-26Z-1836-2017Class IIValleylab Laparoscopic HandsetCOVIDIEN MEDTRONIC
2017-04-26Z-1837-2017Class IIAlcon Patient Care Kits Product Usage: A Patient Care Kit is an…Alcon Research, Ltd.
2017-04-26Z-1838-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 5Smith & Nephew, Inc.
2017-04-26Z-1839-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number:…Smith & Nephew, Inc.
2017-04-26Z-1840-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 6Smith & Nephew, Inc.
2017-04-26Z-1841-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number:…Smith & Nephew, Inc.
2017-04-26Z-1842-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 7Smith & Nephew, Inc.
2017-04-26Z-1843-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number:…Smith & Nephew, Inc.
2017-04-26Z-1844-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 8Smith & Nephew, Inc.
2017-04-26Z-1845-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number:…Smith & Nephew, Inc.
2017-04-26Z-1846-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 9Smith & Nephew, Inc.
2017-04-26Z-1847-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number:…Smith & Nephew, Inc.
2017-04-26Z-1848-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 10Smith & Nephew, Inc.
2017-04-26Z-1849-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number:…Smith & Nephew, Inc.
2017-04-26Z-1850-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 11Smith & Nephew, Inc.
2017-04-26Z-1851-2017Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number:…Smith & Nephew, Inc.
2017-04-26Z-1852-2017Class IIIt is recommended for patients with weight/size between 4-22 lbsVerathon Inc
2017-04-26Z-1853-2017Class IINAMIC Fluid Delivery SetAngiodynamics Inc. (Navilyst Medical Inc.)
2017-04-26Z-1854-2017Class IIPeri-LocSmith & Nephew, Inc.
2017-04-26Z-1855-2017Class IID-RADSmith & Nephew, Inc.
2017-04-26Z-1856-2017Class IID-RADSmith & Nephew, Inc.
2017-04-26Z-1857-2017Class IID-RADSmith & Nephew, Inc.
2017-04-26Z-1858-2017Class IIvarious polyethylene implants BIO PLUG 10MM Product Usage: Non-weight…Zimmer Biomet, Inc.
2017-04-26Z-1859-2017Class IIvarious polyethylene implants ExtremitiesZimmer Biomet, Inc.
2017-04-26Z-1860-2017Class IIvarious polyethylene implants Hips Active Articulation ArComXL…Zimmer Biomet, Inc.
2017-04-26Z-1861-2017Class IIvarious polyethylene implants Knees Revision Tibial Tray Systems…Zimmer Biomet, Inc.
2017-04-26Z-1862-2017Class IIvarious polyethylene implants Custom parts Product Usage: CustomZimmer Biomet, Inc.
2017-04-26Z-1863-2017Class IIvarious polyethylene implants Sports Med Repicci II Tibial Components…Zimmer Biomet, Inc.
2017-04-26Z-1864-2017Class IISoftware version 4BD LIFE SCIENCES
2017-04-26Z-1865-2017Class IIVacutainer Tubes Vacutainer tubes are intended for clinical…Avid Medical, Inc.
2017-04-26Z-1866-2017Class IIBD Viper LT softwareBd Diagnostic
2017-04-26Z-1867-2017Class II216 Wilson Frame PadsMizuho OSI
2017-04-26Z-1868-2017Class IISmartTools Knee System Orthopedic Stereotaxic InstrumentOrthosoft, Inc. dba Zimmer CAS
2017-04-26Z-1869-2017Class IIElcam Minimal Residual Volume Luer-activated Swabable-stockcockElcam Medical, Inc.
2017-04-26Z-1870-2017Class IIBush DL Ureteral Illuminating Catheter Set Bush SL Ureteral…Cook Inc.
2017-04-26Z-1871-2017Class IISURESTEP TrayC.R. Bard, Inc.
2017-04-26Z-1872-2017Class IIPGCL [polyCP Medical Inc
2017-04-26Z-1873-2017Class IILaerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 mlLaerdal Medical Corporation
2017-04-19Z-1702-2017Class IThe Medtronic StrataMR adjustable valves and shunts are designed to…Medtronic Neurosurgery
2017-04-19Z-1754-2017Class IIMEDTECH ROSA Brain 3Zimmer Biomet, Inc.
2017-04-19Z-1755-2017Class IIMEDTECH ROSA Spine 1Zimmer Biomet, Inc.
2017-04-19Z-1756-2017Class IISterile Handpiece SheathsConMed Corporation
2017-04-19Z-1757-2017Class IISterile Handpiece SheathsConMed Corporation
2017-04-19Z-1758-2017Class IISterile Handpiece SheathsConMed Corporation
2017-04-19Z-1759-2017Class IISterile Handpiece SheathsConMed Corporation
2017-04-19Z-1760-2017Class IIHYFRECATOR 2000 HANDPIECE SHEATHConMed Corporation
2017-04-19Z-1761-2017Class IISpecimen Gate LaboratoryPerkinElmer Life and Analytical Sciences, Wallac, OY
2017-04-19Z-1762-2017Class IIiConnect Enterprise ArchiveMerge Healthcare, Inc.
2017-04-19Z-1763-2017Class IICobas 8100 bi-directional reformatterRoche Diagnostics Corporation
2017-04-19Z-1764-2017Class IICobas 8100 uni-directional reformatterRoche Diagnostics Corporation
2017-04-19Z-1765-2017Class IIVITROS Immunodiagnostic Products NT-pro BNP Reagent PackORTHO-CLINICAL DIAGNOSTICS
2017-04-19Z-1766-2017Class IIThe PreludeSYNC Radial Compression Device is a sterileMerit Medical Systems, Inc.
2017-04-19Z-1767-2017Class IICADD¿ Administration SetSmiths Medical ASD Inc.
2017-04-19Z-1768-2017Class IIBedside monitor CSM-1901Nihon Kohden America Inc
2017-04-19Z-1769-2017Class IICustom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part…Datascope Corporation
2017-04-19Z-1770-2017Class IICombi Dockable Neurosurgery table for the Siemens MAGNETOM AeraSiemens Medical Solutions USA, Inc
2017-04-19Z-1771-2017Class IIViperWire Advance Peripheral Guide Wire with Flex TipCardiovascular Systems Inc
2017-04-19Z-1772-2017Class IIDeltaDraegar Medical Systems, Inc.
2017-04-19Z-1773-2017Class IIDelta XLDraegar Medical Systems, Inc.
2017-04-19Z-1774-2017Class IIKappaDraegar Medical Systems, Inc.
2017-04-19Z-1775-2017Class IIRefinity Rotational Intravascular UltrasoundVolcano Corporation
2017-04-19Z-1776-2017Class IIRefinity Short Tip Rotational Intravascular UltrasoundVolcano Corporation
2017-04-19Z-1777-2017Class IIWelch Allyn ProBP 2400 Digital Blood Pressure Device #2400Welch Allyn Inc
2017-04-19Z-1778-2017Class IIMerge Hemo softwareMerge Healthcare, Inc.
2017-04-19Z-1779-2017Class IIVivid E95/E90/E80GE Healthcare, LLC
2017-04-19Z-1780-2017Class IIVivid S60/S70/S60N/S70NGE Healthcare, LLC
2017-04-19Z-1781-2017Class IIBoston Scientific Imager II Angiographic CatheterBoston Scientific Corporation
2017-04-19Z-1782-2017Class IICentricity PACS Web DiagnosticGe Medical Systems Information T
2017-04-19Z-1783-2017Class IICataract KitWindstone Medical Packaging, Inc.
2017-04-19Z-1784-2017Class IICataract KitWindstone Medical Packaging, Inc.
2017-04-19Z-1785-2017Class IICataract PackWindstone Medical Packaging, Inc.
2017-04-19Z-1786-2017Class IICustom TrayWindstone Medical Packaging, Inc.
2017-04-19Z-1787-2017Class IIDicken Eye PackWindstone Medical Packaging, Inc.
2017-04-19Z-1788-2017Class IIDrWindstone Medical Packaging, Inc.
2017-04-19Z-1789-2017Class IIENT PackWindstone Medical Packaging, Inc.
2017-04-19Z-1790-2017Class IIEye Cataract PackWindstone Medical Packaging, Inc.
2017-04-19Z-1791-2017Class IIEye PackWindstone Medical Packaging, Inc.
2017-04-19Z-1792-2017Class IILasik TrayWindstone Medical Packaging, Inc.
2017-04-19Z-1793-2017Class IIMinor Operation KitWindstone Medical Packaging, Inc.
2017-04-19Z-1794-2017Class IIOphthalmic PackWindstone Medical Packaging, Inc.
2017-04-19Z-1795-2017Class IIOrtho Basic PackWindstone Medical Packaging, Inc.
2017-04-19Z-1796-2017Class IIPlastic PackWindstone Medical Packaging, Inc.
2017-04-19Z-1797-2017Class IIPRK TrayWindstone Medical Packaging, Inc.
2017-04-19Z-1798-2017Class IISetup PackWindstone Medical Packaging, Inc.
2017-04-19Z-1799-2017Class IIVitrectomy KitWindstone Medical Packaging, Inc.
2017-04-19Z-1800-2017Class IIVitrectomy PackWindstone Medical Packaging, Inc.
2017-04-19Z-1801-2017Class IIVIDAS Estradiol IIBioMerieux SA
2017-04-19Z-1802-2017Class IIVolt Resistance Heated Neck Garment Deep penetrating heat garment and…2k Innovations Inc.
2017-04-19Z-1803-2017Class IIVolt Resistance Heated Lower Back Garment Deep penetrating heat…2k Innovations Inc.
2017-04-19Z-1804-2017Class IIVolt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat…2k Innovations Inc.
2017-04-19Z-1805-2017Class IIVolt Resistance Heated Therapy Foot Wrap Deep penetrating heat…2k Innovations Inc.
2017-04-19Z-1806-2017Class IIVolt Resistance Heated Therapy Knee Wrap Deep penetrating heat…2k Innovations Inc.
2017-04-19Z-1807-2017Class IIVolt Resistance Heated Elbow Garment Deep penetrating heat garment…2k Innovations Inc.
2017-04-19Z-1808-2017Class IIVolt Resistance Frostie Heated Gloves2k Innovations Inc.
2017-04-19Z-1809-2017Class IIVolt Resistance Heated Socks2k Innovations Inc.
2017-04-19Z-1810-2017Class IIVolt Resistance Heated Slipper Black2k Innovations Inc.
2017-04-19Z-1811-2017Class IIVolt Resistance Heated Slipper Gray2k Innovations Inc.
2017-04-19Z-1812-2017Class IIVolt Resistance Heated Slipper2k Innovations Inc.
2017-04-19Z-1813-2017Class IIVolt Resistance Unisex Rechargeable Heated Slipper2k Innovations Inc.
2017-04-19Z-1814-2017Class IIAESCULAP MINOP InVent 30 Trocar SystemAesculap Implant Systems LLC
2017-04-19Z-1815-2017Class IIRadiation Therapy Treatment Planning SystemRAYSEARCH LABORATORIES AB
2017-04-19Z-1816-2017Class IITotalCare Bed SystemsHill-Rom, Inc.
2017-04-19Z-1817-2017Class IINordson Micromedics FibriJet Endoscopic Catheter IntroducerMicromedics, Inc.
2017-04-19Z-1818-2017Class IIKeystone Dental IncKeystone Dental Inc
2017-04-19Z-1819-2017Class IIda Vinci Xi EndoWrist Suction IrrigatorIntuitive Surgical, Inc.
2017-04-12Z-1704-2017Class IIBeckman Coulter Chemistry Analyzer AU680/AU5800Beckman Coulter Inc.
2017-04-12Z-1705-2017Class IIThe CG+ Arrow PIC Catheters permit venous access to the central…Arrow International Inc
2017-04-12Z-1706-2017Class IIMobile Diagnostic X-Ray System with Digital PanelPhilips Healthcare Inc.
2017-04-12Z-1707-2017Class IIPhilips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352…Philips Electronics North America Corporation
2017-04-12Z-1708-2017Class IIeCare Coordinator Product Usage: is software intended for use in data…Philips Visicu
2017-04-12Z-1709-2017Class IIAccess 2 Immunoassay SystemsBeckman Coulter Inc.
2017-04-12Z-1710-2017Class IIAccess 2 assay Immunoassay SystemBeckman Coulter Inc.
2017-04-12Z-1711-2017Class IIUniCel DxC 600i SYNCHRON Access Clinical SystemBeckman Coulter Inc.
2017-04-12Z-1712-2017Class IIIADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc.
2017-04-12Z-1713-2017Class IINucliSENS Lysis BufferBioMerieux SA
2017-04-12Z-1714-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1715-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1716-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1717-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1718-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1719-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1720-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1721-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1722-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1723-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1724-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1725-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1726-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1727-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1728-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1729-2017Class IISTAPLERIntuitive Surgical, Inc.
2017-04-12Z-1730-2017Class IIPOST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually…Centurion Medical Products Corporation
2017-04-12Z-1731-2017Class IIOPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are…Centurion Medical Products Corporation
2017-04-12Z-1732-2017Class IIOPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are…Centurion Medical Products Corporation
2017-04-12Z-1733-2017Class IIEYE KIT The Covidien Curity Oval Eye Pads are individually packaged…Centurion Medical Products Corporation
2017-04-12Z-1734-2017Class IIPOST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye…Centurion Medical Products Corporation
2017-04-12Z-1735-2017Class IIOPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are…Centurion Medical Products Corporation
2017-04-12Z-1736-2017Class IICUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually…Centurion Medical Products Corporation
2017-04-12Z-1737-2017Class IIBond Elut OMSAgilent Technologies, Inc.
2017-04-12Z-1738-2017Class IIDX-D600AGFA Healthcare Corp.
2017-04-12Z-1739-2017Class IICovidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a…Covidien LLC

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