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High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·1,025 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·1,028 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide v...
Medical Implants·1,867 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·475 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·2,784 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D15...
Medical Implants·8,821 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·153 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·4,372 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154...
Medical Implants·8,890 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·250 affected·Jun 21, 2018
High RiskFDA
Icelandic Provisions Inc.
Icelandic Provisions Vanilla Skyr cups, 5.3oz package, UPC: 854074006068
Food·1,884 affected·Jun 20, 2018
High RiskFDA
Advanced Pharma Inc.
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated...
Drugs·100 affected·Jun 20, 2018
High RiskFDA
Boston Scientific Corporation
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R...
Cardiac Devices·793 affected·Jun 20, 2018
High RiskFDA
Nico Corp.
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Medical Devices·204 affected·Jun 19, 2018
High RiskFDA
Stryker Sustainability Solutions
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Descript...
Surgical Devices·4,848 affected·Jun 19, 2018
High RiskFDA
Lemaitre Vascular, Inc.
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an ana...
Medical Devices·0 affected·Jun 19, 2018
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiolo...
Medical Devices·264 affected·Jun 18, 2018
High RiskFDA
Bovie Medical Corporation
J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma ...
Surgical Devices·1,176 affected·Jun 18, 2018
High RiskFDA
Del Monte Fresh Produce N.a., Inc. Hq
Del Monte 6 oz. Veg Tray w/dip; Del Monte 12 oz. Veg Tray w/dip contains baby carrots, broccoli, cauliflower and dill dip
Baby Food & Formula·65,880 affected·Jun 15, 2018
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Medical Devices·972 affected·Jun 15, 2018
High RiskFDA
Shimadzu Medical Systems Usa Com
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, periph...
Cardiac Devices·1 affected·Jun 15, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·1,882 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·2,869 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·451 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·400 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·440 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·492 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·2,268 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·1,397 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·0 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·179 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·451 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·196 affected·Jun 14, 2018
High RiskFDA
Abbott Laboratories, Inc.
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics Syst...
Medical Devices·2,521 affected·Jun 14, 2018
High RiskFDA
Maquet Sas
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; A...
Surgical Devices·151 affected·Jun 14, 2018
High RiskFDA
Lupin Somerset
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), ...
Drugs·2,229,052 affected·Jun 13, 2018
High RiskFDA
Beekley Corporation
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Medical Devices·3,384,024 affected·Jun 13, 2018
High RiskFDA
Beekley Corporation
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Medical Devices·3,384,024 affected·Jun 13, 2018
High RiskFDA
Bard Medical Division
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indica...
Medical Devices·5,608 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 7402...
Medical Devices·64,642 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 7402...
Medical Devices·42,050 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 7402121...
Medical Devices·10,792 affected·Jun 13, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parklan...
Drugs·20 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Adv...
Drugs·120 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella ...
Drugs·225 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables H...
Oral Drugs·220 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of H...
Drugs·480 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houst...
Drugs·2,500 affected·Jun 12, 2018