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High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor MN, Model Number 10094142
Medical Devices·23 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis dMP, Model Number 7555365
Medical Devices·32 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis dBC, Model Number 7728392
Medical Devices·53 affected·Jun 12, 2019
High RiskFDA
Zoll Medical Corporation
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibr...
Cardiac Devices·1,969 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling, Model Number 10094137
Medical Devices·428 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis dBA, Model Number 7555357
Medical Devices·85 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis dFA, Model Number 7555373
Medical Devices·39 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor, Model Number 10094135
Medical Devices·170 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis dTA, Model Number 7008605
Medical Devices·178 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane, Model Number 10094141
Medical Devices·268 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zeego, Model Number 10280959
Medical Devices·117 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee multi, Model Number 10094139
Medical Devices·89 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis TA, Model Number 7007755
Medical Devices·5 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis dFC, Model Number 7727717
Medical Devices·19 affected·Jun 12, 2019
High RiskFDA
Beckman Coulter Inc.
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 60...
Diagnostic Devices·10,145 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Life Technologies Corporation
StemPro¿ MSC SFM CTS"
Medical Devices·4,724 affected·Jun 11, 2019
High RiskFDA
Randox Laboratories, Limited
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the qualit...
Diagnostic Devices·149 affected·Jun 11, 2019
High RiskFDA
Preferred Pharmaceuticals, Inc
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bot...
Drugs·192 affected·Jun 10, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT , Model Number 882482
Medical Devices·427 affected·Jun 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Medical Devices·1,257 affected·Jun 10, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scala...
Diagnostic Devices·1,763 affected·Jun 10, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView SPECT, Model Number 882480
Medical Devices·696 affected·Jun 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Medical Devices·92 affected·Jun 10, 2019
High RiskFDA
Molded Products Inc
Luer Lock Set - Catalog # MPC-125, for IV administration sets.
Medical Devices·130,000 affected·Jun 10, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView X , Model Number 882478
Medical Devices·117 affected·Jun 10, 2019
High RiskFDA
Burlington Medical, Llc
Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are desig...
Medical Devices·1 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatt...
Medical Devices·3 affected·Jun 7, 2019
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536...
Cardiac Devices·97,794 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF...
Medical Devices·104 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed...
Medical Devices·6 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Medical Devices·7 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, S...
Medical Devices·22 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, S...
Medical Devices·129 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, R...
Medical Devices·48 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, R...
Medical Devices·310 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, S...
Medical Devices·37 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed t...
Medical Devices·39 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SET...
Medical Devices·807 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are...
Medical Devices·23 affected·Jun 7, 2019
High RiskFDA
Burlington Medical, Llc
Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R Product Usage: Pro...
Medical Devices·210 affected·Jun 7, 2019
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Oral Drugs·2,924,000 affected·Jun 6, 2019