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All Product Recalls
49,209 recalls (high severity)
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Fol...
Surgical Devices330 affectedJun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices1,000 affectedJun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley C...
Surgical Devices1,588 affectedJun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices14,326 affectedJun 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, D153...
Medical Implants103 affectedJun 21, 2018
High RiskFDA
Ossur Americas
Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML...
Medical Devices138 affectedJun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices1,025 affectedJun 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 Devices1,028 affectedJun 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 Implants1,867 affectedJun 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 Devices475 affectedJun 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 Devices2,784 affectedJun 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 Implants8,821 affectedJun 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 Devices153 affectedJun 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 Devices4,372 affectedJun 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 Implants8,890 affectedJun 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 Devices250 affectedJun 21, 2018
High RiskFDA
Icelandic Provisions Inc.
Icelandic Provisions Vanilla Skyr cups, 5.3oz package, UPC: 854074006068
Food1,884 affectedJun 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...
Drugs100 affectedJun 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 Devices793 affectedJun 20, 2018
High RiskFDA
Nico Corp.
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Medical Devices204 affectedJun 19, 2018
High RiskFDA
Stryker Sustainability Solutions
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Descript...
Surgical Devices4,848 affectedJun 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 Devices0 affectedJun 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 Devices264 affectedJun 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 Devices1,176 affectedJun 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 & Formula65,880 affectedJun 15, 2018
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Medical Devices972 affectedJun 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 Devices1 affectedJun 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
Drugs1,882 affectedJun 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
Drugs2,869 affectedJun 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
Drugs451 affectedJun 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
Drugs400 affectedJun 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
Drugs440 affectedJun 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
Drugs492 affectedJun 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
Drugs2,268 affectedJun 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
Drugs1,397 affectedJun 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
Drugs0 affectedJun 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
Drugs179 affectedJun 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
Drugs451 affectedJun 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
Drugs196 affectedJun 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 Devices2,521 affectedJun 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 Devices151 affectedJun 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), ...
Drugs2,229,052 affectedJun 13, 2018
High RiskFDA
Beekley Corporation
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Medical Devices3,384,024 affectedJun 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 Devices3,384,024 affectedJun 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 Devices5,608 affectedJun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 7402...
Medical Devices64,642 affectedJun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 7402...
Medical Devices42,050 affectedJun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 7402121...
Medical Devices10,792 affectedJun 13, 2018