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High RiskFDA
Siemens Medical Solutions Usa, Inc
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposu...
Medical Devices·314 affected·Apr 6, 2020
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bot...
Oral Drugs·0 affected·Apr 3, 2020
High RiskFDA
Philips North America, Llc
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Intervent...
Medical Devices·22 affected·Apr 3, 2020
High RiskFDA
Skeletal Kinetics, Llc
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler ind...
Surgical Devices·125 affected·Apr 3, 2020
High RiskFDA
C.a. Greiner & Sohne Gesellschaftmbh
VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer ...
Medical Devices·90,400 affected·Apr 3, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is repla...
Medical Devices·270 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced...
Medical Devices·1,724 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is ...
Medical Devices·278 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is repla...
Medical Devices·647 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replac...
Medical Devices·436 affected·Apr 2, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Medical Devices·204 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replace...
Medical Devices·417 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is rep...
Medical Devices·995 affected·Apr 2, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 6...
Oral Drugs·25,944 affected·Apr 1, 2020
High RiskFDA
Aesculap Implant Systems Llc
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Medical Devices·399 affected·Apr 1, 2020
High RiskFDA
Aesculap Implant Systems Llc
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Medical Devices·3,392 affected·Apr 1, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The...
Medical Devices·0 affected·Apr 1, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: T...
Medical Devices·0 affected·Apr 1, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Ther...
Drugs·7,957 affected·Mar 31, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Thera...
Drugs·5,614 affected·Mar 31, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Thera...
Drugs·14,142 affected·Mar 31, 2020
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon O...
Medical Devices·0 affected·Mar 31, 2020
High RiskFDA
Par Pharmaceutical Inc.
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par...
Oral Drugs·29,352 affected·Mar 30, 2020
High RiskFDA
Boston Scientific Corporation
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, abla...
Surgical Devices·146,633 affected·Mar 30, 2020
High RiskFDA
Beckman Coulter Inc.
iChem¿VELOCITY Urine Chemistry System-
Medical Devices·1,557 affected·Mar 30, 2020
High RiskFDA
Elekta Inc
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Medical Devices·25 affected·Mar 30, 2020
High RiskFDA
Edwards Lifesciences, Llc
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Surgical Devices·597 affected·Mar 27, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MU...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Avet Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 2315...
Oral Drugs·12,168 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 ...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Avet Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10)...
Oral Drugs·2,904 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , C...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MU...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is in...
Medical Devices·3 affected·Mar 26, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Medical Devices·83 affected·Mar 26, 2020
High RiskFDA
Gentell, Inc
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model ...
Surgical Devices·85,586 affected·Mar 26, 2020
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pen...
Surgical Devices·40 affected·Mar 26, 2020
High RiskFDA
Gentell, Inc
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model ...
Surgical Devices·4,348 affected·Mar 26, 2020
High RiskFDA
Becton Dickinson & Company
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403...
Surgical Devices·900 affected·Mar 26, 2020
High RiskFDA
Gentell, Inc
Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11...
Surgical Devices·4,419 affected·Mar 26, 2020
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pha...
Oral Drugs·0 affected·Mar 25, 2020
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pha...
Oral Drugs·0 affected·Mar 25, 2020
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Phar...
Oral Drugs·0 affected·Mar 25, 2020
High RiskFDA
Health Harvest, Llc
Audrey's Chia Cookies Chocolate Chip, 4 OZ flexible pouch packaging, UPC Code: 858652007003, Manufactured for Health Harvest, LLC, P.O. B...
Bakery & Grains·1,199 affected·Mar 24, 2020
High RiskFDA
Health Harvest, Llc
Audrey's Chia Cookies Almond, 4 OZ flexible pouch packaging, UPC Code: 858652007027, Manufactured for Health Harvest, LLC, P.O. Box 20634...
Bakery & Grains·1,199 affected·Mar 24, 2020
High RiskFDA
Health Harvest, Llc
Audrey's Chia Cookies Peanut Butter, 4 OZ flexible pouch packaging, UPC Code: 858652007034, Manufactured for Health Harvest, LLC, P.O. Bo...
Dairy·1,199 affected·Mar 24, 2020
High RiskFDA
Herbal Doctor Remedies
Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Drugs·0 affected·Mar 24, 2020