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High RiskFDA
Biomerieux, Inc.
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the ide...
Diagnostic Devices·10,784 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
Surgical Devices·62 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
Surgical Devices·3 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for cardiovascular use
Surgical Devices·32,484 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT SH .070", REF SA63DRIGHTSH. for cardiovascular use
Surgical Devices·87 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
Surgical Devices·12 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use
Surgical Devices·6 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5, .070", REF SA6AL15. for cardiovascular use
Surgical Devices·208 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. for cardiovascular use
Surgical Devices·113 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. for cardiovascular use
Surgical Devices·0 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU30. for cardiovascular use
Surgical Devices·2,607 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use
Surgical Devices·9 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F FR3.5, .070", REF SA6FR35. for cardiovascular use
Surgical Devices·9 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use
Surgical Devices·29 affected·Mar 15, 2019
RecallFDA
Cytocell Ltd.
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Diagnostic Devices·19 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use
Surgical Devices·80 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
Surgical Devices·1,226 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL3.5, .070", REF SA6JCL35. for cardiovascular use
Surgical Devices·11 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII. for cardiovascular use
Surgical Devices·6 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
Surgical Devices·23 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use
Surgical Devices·6 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT, .070", REF SA6ERADR. for cardiovascular use
Surgical Devices·34 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascular use
Surgical Devices·27 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0, .070", REF SA6SAL10. for cardiovascular use
Surgical Devices·191 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. for cardiovascular use
Surgical Devices·0 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
Surgical Devices·22 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use
Surgical Devices·51 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 .070", REF SA6MAC30. for cardiovascular use
Surgical Devices·206 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use
Surgical Devices·8 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 90CM, 070", REF SA6JL40D. for cardiovascular use
Surgical Devices·14 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use
Surgical Devices·246 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. for cardiovascular use
Surgical Devices·12 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular use
Surgical Devices·20 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use
Surgical Devices·18 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use
Surgical Devices·6,219 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for cardiovascular use
Surgical Devices·159 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0 SH, .070", REF SA6AL10SH. for cardiovascular use
Surgical Devices·364 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
Surgical Devices·17 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070", REF SA6SCR35. for cardiovascular use
Surgical Devices·45 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for cardiovascular use
Surgical Devices·3 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for cardiovascular use
Surgical Devices·56 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use
Surgical Devices·14 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. for cardiovascular use
Surgical Devices·4 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. for cardiovascular use
Surgical Devices·305 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use
Surgical Devices·2 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0 SH, .070", REF SA6AL30SH. for cardiovascular use
Surgical Devices·33 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for cardiovascular use
Surgical Devices·20 affected·Mar 15, 2019
High RiskFDA
Response Biomedical Corp.
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #0703...
Cardiac Devices·543 affected·Mar 15, 2019