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

59,476 records, page 944 of 1190
FDA device recalls, page 944 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0281-2010Stryker Medical eye surgery stretcher, Stryker Medical, Portage, MI; Model...Stryker MedicalFPO
Z-0280-2010Stryker Medical trauma stretcher, Stryker Medical, Portage, MI; Model 1027. Wheeled...Stryker MedicalFPO
Z-0279-2010Stryker Medical M-Series stretcher, Stryker Medical, Portage, MI; Model 1007...Stryker MedicalFPO
Z-0278-2010Stryker Medical wide transport stretcher, Stryker Medical, Portage, MI; Model 738...Stryker MedicalFPO
Z-2213-2009Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model...Stryker MedicalFNL
Z-0277-2010Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 734. Wheeled...Stryker MedicalFPO
Z-0180-2010Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North...Boston Scientific CorporationLWS
Z-0393-2011Innova 2000 The principle system components include a C-arm, image acquisition...GE HealthcareMQB
Z-0392-2011Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The...GE HealthcareMQB
Z-0367-2010Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel...Zimmer GmbHFZX
Z-0038-2010AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.Airgas Puritan MedicalCAN
Z-0037-2010AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.Airgas Puritan MedicalCAN
Z-1367-2011Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery...Medtronic IrelandNIQ
Z-2042-2009Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA...Zimmer GmbHHWE
Z-0410-2011Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The...GE HealthcareMQB
Z-0409-2011Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE...GE HealthcareMQB
Z-0408-2011Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane...GE HealthcareMQB
Z-0407-2011Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems...GE HealthcareMQB
Z-0503-2010Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14Alphatec Spine, Inc.KWP
Z-0502-2010Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12Alphatec Spine, Inc.KWP
Z-2015-2009Boston Scientific Expo, Angiographic Catheter, Sterilized with ethylene oxide gas, Made...Boston Scientific CorporationDQO
Z-2014-2009Boston Scientific Impulse Flextrusion Shaft, Angiographic Catheter, Sterilized with...Boston Scientific CorporationDQO
Z-2013-2009Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in...Boston Scientific CorporationDQO
Z-2915-2011GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N...Philips North America LLCKPS
Z-1012-2010PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A...Polymer Technology SystemsCGA
Z-2047-2011Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin...Siemens Healthcare Diagnostics Inc.CFT
Z-0160-2010Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with...Stryker ImagingLMB
Z-2239-2009ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product...3M ImtecLLZ
Z-0198-2010Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm...Zimmer GmbHLPH
Z-0496-2010Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE...GE HealthcareJAK
Z-0495-2010Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha...GE HealthcareJAK
Z-0494-2010Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW...GE HealthcareJAK
Z-0172-2010MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i...Wescam IncRET
Z-1436-2010iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.Elekta LimitedIYE
Z-0168-2010Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or...Stryker ImagingLMB
Z-2030-2009Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external...Physio Control, Inc.MKJ
Z-2048-2009Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product...Carl Zeiss Meditec IncHLI
Z-1944-2009Hudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41...Teleflex MedicalBZA
Z-1943-2009Hudson RICA Sheridan, Sher-I-Bronch Accessory Pack, Teleflex Medical, Research Triangle...Teleflex MedicalBZA
Z-1942-2009Hudson RICA Sheridan, ET Tube, Sher-I-Bronch RS, 28FR, 35 FR, 37 FR, 39FR and 41 FR...Teleflex MedicalBZA
Z-1941-2009Hudson RICA Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR...Teleflex MedicalBZA
Z-1940-2009Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC...Teleflex MedicalBZA
Z-2007-2009MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. ConMed...Linvatec CorporationHWE
Z-2051-2009REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED...Linvatec CorporationGEI
Z-0067-2010Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only...Linvatec CorporationHST
Z-1952-2009Mpower PRO6200 Single Trigger Modular Handpiece, Mpower PRO6202 Battery Two-Trigger...Linvatec CorporationHRX
Z-2041-2009ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE...Linvatec CorporationHTT
Z-1951-2009PowerProMax PRO5100M Battery Single Trigger, PowerProMax PRO5200M Battery Two...Linvatec CorporationHRX
Z-1950-2009PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250...Linvatec CorporationHRX
Z-2209-2009Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure...Boston Scientific CorporationMNB