33 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Recall
Open, Classified
·Biosense Webster, Inc.·Product code DYB·February 21, 2023
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Recall
Open, Classified
·Biosense Webster, Inc.·Product code DYB·February 21, 2023
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180 and counterclockwise = 180. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.
FDA Recall
Open, Classified
·Biosense Webster, Inc.·Product code DYB·February 16, 2024
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head; 3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head; 3205.47.028 Klassic BiPolar Head, 47 mm OD, 28 mm Head; 3205.48.028 Klassic BiPolar Head, 48 mm OD, 28 mm Head; 3205.49.028 Klassic BiPolar Head, 49 mm OD, 28 mm Head; 3205.50.028 Klassic BiPolar Head, 50 mm OD, 28 mm Head; 3205.51.028 Klassic BiPolar Head, 51 mm OD, 28 mm Head; 3205.52.028 Klassic BiPolar Head, 52 mm OD, 28 mm Head; 3205.53.028 Klassic BiPolar Head, 53 mm OD, 28 mm Head; 3205.54.028 Klassic BiPolar Head, 54 mm OD, 28 mm Head; 3205.55.028 Klassic BiPolar Head, 55 mm OD, 28 mm Head; 3205.56.028 Klassic BiPolar Head, 56 mm OD, 28 mm Head; 3205.58.028 Klassic BiPolar Head, 58 mm OD, 28 mm Head; 3205.60.028 Klassic BiPolar Head, 60 mm OD, 28 mm Head
FDA Recall
Open, Classified
·Total Joint Orthopedics, Inc.·Product code KWY·September 23, 2025
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
FDA Recall
Open, Classified
·Remel Inc·Product code JWY·January 10, 2022
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code KWY·October 15, 2024
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM
FDA Recall
Open, Classified
·BioPro, Inc.·Product code KWY·September 9, 2025
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022