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High RiskFDA
Smiths Medical Asd Inc.
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: ...
Medical Devices·7,840 affected·Feb 11, 2019
High RiskFDA
Fenwal Inc
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood ...
Medical Devices·198 affected·Feb 11, 2019
High RiskFDA
Smiths Medical Asd Inc.
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use...
Medical Devices·109,000 affected·Feb 11, 2019
High RiskFDA
World Waters, Llc Dba Wtrmln Wtr
Watermelon, WTRMLNWTR Cold Pressured, 12fl oz, Watermelon Flavor, Refrigerated
Beverages·277,230 affected·Feb 8, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, P...
Drugs·8,500 affected·Feb 8, 2019
High RiskFDA
Mcdaniel Life-line Llc
Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life-Line tm and Zinc...
Supplements·150 affected·Feb 8, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 244...
Injectable Drugs·2,840 affected·Feb 8, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Av...
Drugs·250 affected·Feb 8, 2019
High RiskFDA
Mcdaniel Life-line Llc
Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027
Drugs·0 affected·Feb 8, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th A...
Drugs·4,950 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Medical Devices·563,000 affected·Feb 8, 2019
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, ped...
Cardiac Devices·10,699 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 23G x 1", Product Code NN2325R
Medical Devices·30,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Medical Devices·729,000 affected·Feb 8, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-800...
Surgical Devices·9 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 1", Product Code 100211
Medical Devices·444,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
Medical Devices·638,000 affected·Feb 8, 2019
High RiskFDA
Elekta, Inc.
Monaco Radiation Treatment Planning (RTP) System
Medical Devices·14 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 18G x 1", Product Code NN1825R
Medical Devices·810,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 30G x 1/2", Product Code NN3013R
Medical Devices·81,000 affected·Feb 8, 2019
High RiskFDA
Birdseed Food Co Llc
Craft Granola Goldenola Turmeric & Ginger, packaged in 3 oz. and 11 oz. poly bag, UPC: 860157002028 and 8601570020135
Bakery & Grains·440 affected·Feb 7, 2019
High RiskFDA
Willamette Valley Pie Company, Llc.
Frozen IQF Red Raspberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is 0 22518 87750 9. The lab...
Produce·1,221 affected·Feb 7, 2019
High RiskFDA
Willamette Valley Pie Company, Llc.
Frozen IQF Strawberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is UPC: 0 22518 87710 3. The...
Produce·1,448 affected·Feb 7, 2019
High RiskFDA
Ecolab Inc
Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-5...
Topical Drugs·105 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 4759...
Topical Drugs·30 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bo...
Topical Drugs·118 affected·Feb 6, 2019
High RiskFDA
Advanced Pharma Inc.
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, R...
Injectable Drugs·100 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 4759...
Drugs·67 affected·Feb 6, 2019
High RiskFDA
Ecolab Inc
Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC ...
Topical Drugs·22 affected·Feb 6, 2019
High RiskFDA
Lw Scientific, Inc.
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in he...
Medical Devices·142 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Medical Devices·3 affected·Feb 6, 2019
High RiskFDA
Medica Corporation
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in w...
Diagnostic Devices·87 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Medical Devices·1 affected·Feb 6, 2019
High RiskFDA
Lw Scientific, Inc.
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in ...
Medical Devices·16 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Medical Devices·4 affected·Feb 6, 2019
High RiskFDA
Abbott Ireland Diagnostics Division
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CM...
Diagnostic Devices·2,724 affected·Feb 5, 2019
High RiskFDA
Akorn Inc
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerf...
Ophthalmic Drugs·78,120 affected·Feb 4, 2019
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
Injectable Drugs·475,320 affected·Feb 4, 2019
High RiskFDA
Moller Vital
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
Medical Devices·427 affected·Feb 4, 2019
High RiskFDA
Encore Medical, Lp
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Medical Devices·410 affected·Feb 4, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill we...
Inhaled / Nasal Drugs·10,390 affected·Feb 1, 2019
High RiskFDA
Becton Dickinson & Company
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Medical Devices·460,800 affected·Feb 1, 2019
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 ...
Medical Devices·26 affected·Feb 1, 2019
High RiskFDA
Becton Dickinson & Company
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Medical Devices·428,800 affected·Feb 1, 2019
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 ...
Medical Devices·24 affected·Feb 1, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - ...
Oral Drugs·10,656 affected·Jan 31, 2019
High RiskFDA
Medline Industries Inc
Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box inc...
Medical Devices·750 affected·Jan 31, 2019
High RiskFDA
Dunkin Brands Inc
DUNKIN' DONUTS MULTIGRAIN BAGEL DOUGH PRODUCT APPROVED BY: DUNKIN'DONUTS Unit wt: 4.5oz Count: 104 units Net Wt: 29 lb 4 oz (13.3 kg) 007...
Food·9,779 affected·Jan 30, 2019