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High RiskFDA
Biomerieux, Inc.
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST0...
Medical Devices·184,374 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product U...
Medical Implants·4,122 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product...
Medical Implants·1,676 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical ...
Medical Implants·8,027 affected·Oct 22, 2018
High RiskFDA
Wom World Of Medicine Ag
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combinat...
Diagnostic Devices·124,180 affected·Oct 22, 2018
High RiskFDA
New Seasons Market Llc
New Seasons Market Hot & Sour Broth, packaged in 24 oz glass jar. UPC 840600108672
Food·1,908 affected·Oct 20, 2018
High RiskFDA
Edney And Sellers, Ltd.
Tropical Dreams Super Premium Ice Cream Vegan Coconut; Pint container; UPC: 7 66150 09985 0 Ingredients: Coconut milk, organic sugar,...
Dairy·28 affected·Oct 19, 2018
High RiskFDA
Cedar's Mediterranean Foods, Inc.
Central Market All Natural Traditional Hummus TOPPED WITH SESAME SEEDS, NET WT 10 OZ (284g).
Food·37,521 affected·Oct 19, 2018
High RiskFDA
Cedar's Mediterranean Foods, Inc.
Central Market All Natural Mediterranean Hummus, NET WT 10 OZ (284g), UPC: 0 41220 91513 2
Food·37,521 affected·Oct 19, 2018
High RiskFDA
Ajinomoto Windsor Inc
Allsup's Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per case
Dairy·10,526 affected·Oct 19, 2018
High RiskFDA
Tyson Foods Discovery Center
Pierre Philly Style Chicken Sandwich, item 1238, 12 units packaged per case Net Wt. 4.99 LBS (2.27 kg) KEEP FROZEN
Meat & Poultry·5,101 affected·Oct 19, 2018
High RiskFDA
Tyson Foods Discovery Center
Steak-EZE Philly Cheesesteak Sandwich, item 06433, Net Wt 5.15 OZ., 4 sandwiches per case KEEP FROZEN
Dairy·1,686 affected·Oct 19, 2018
High RiskFDA
Cedar's Mediterranean Foods, Inc.
HEB Organics TRADITIONAL HUMMUS, NET WT. 8 OZ (227g), 4 pack, UPC: 0 41220 79565 9, Keep Refrigerated contains individual units, NET WT. ...
Food·37,521 affected·Oct 19, 2018
High RiskFDA
Karlsburger Foods, Inc.
Karlsburger Kitchens Roasted Onion Base, item # 23650, Net Weight 50 lbs (22.68 kg), UPC 60492-23650. Karlsburger Foods, Inc., Monticell...
Produce·27 affected·Oct 19, 2018
High RiskFDA
Cedar's Mediterranean Foods, Inc.
HEB Select Ingredients ROASTED GARLIC HUMMUS PREMIUM QUALITY NET WT 8 OZ (227g) UPC 0 41220 33495 7 and NET WT. 16 OZ (1 LB) 454g), UPC 0...
Food·37,521 affected·Oct 19, 2018
High RiskFDA
Tyson Foods Discovery Center
TGIF All American Slider, item 5461, 4 cartons of 4 sandwiches per case NET WT 10 OZ KEEP FROZEN
Frozen Food·103,955 affected·Oct 19, 2018
High RiskFDA
Edney And Sellers, Ltd.
Tropical Dreams Super Premium Ice Cream Chocolate Coconut Macadamia Nut; Pint container; UPC 7 18122 41477 2 Ingredients: Cream, Suga...
Dairy·225 affected·Oct 19, 2018
High RiskFDA
Edney And Sellers, Ltd.
Tropical Dreams Super Premium Ice Cream Toasted Coconut; Pint container; UPC 7 66150 09985 0 Ingredients: Cream, Sugar, coconut milk ...
Dairy·223 affected·Oct 19, 2018
High RiskFDA
Simply Fresh Foods, Inc
Rojo's Autentico Black Bean 5 Layer Dip; Layers of Black Beans, Guacamole, Salsa, sour Cream and Cheddar Cheese. NET WT. 40 oz. (2 Lbs....
Dairy·5,281 affected·Oct 19, 2018
High RiskFDA
Edney And Sellers, Ltd.
Tropical Dreams Super Premium Ice Cream Vegan Chocolate ; Pint container; UPC 685450676526 Ingredients: Coconut milk, organic sugar, ...
Dairy·23 affected·Oct 19, 2018
High RiskFDA
Ajinomoto Windsor Inc
Posada Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per case
Dairy·814 affected·Oct 19, 2018
High RiskFDA
Tyson Foods Discovery Center
Pierre Philly Style Cheesesteak Sandwich, item 1125, 12 units packaged per case Net Wt. 4.65 LBS (2.11 kg) KEEP FROZEN
Dairy·23,362 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·300 affected·Oct 19, 2018
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distr...
Oral Drugs·8,328 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·1,360 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·300 affected·Oct 19, 2018
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle,...
Oral Drugs·0 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, I...
Drugs·20 affected·Oct 19, 2018
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bot...
Oral Drugs·12,432 affected·Oct 19, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort...
Oral Drugs·53,451 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·360 affected·Oct 19, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system dev...
Cardiac Devices·54 affected·Oct 19, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clin...
Medical Devices·1,105 affected·Oct 19, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system ...
Cardiac Devices·15 affected·Oct 19, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes...
Diagnostic Devices·682 affected·Oct 19, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography sys...
Cardiac Devices·14 affected·Oct 19, 2018
High RiskFDA
Cadence Gourmet Llc
Roasted Corn Salsa; Net Weight: 10 lbs. (10 x 1 lb. bags) Corner Bakery Caf¿ Brand Ingredients: Corn, Red Onion, Jalapeno, Lime Juic...
Beverages·55,880 affected·Oct 18, 2018
High RiskFDA
Cadence Gourmet Llc
Cadence Gourmet Balsamic Roasted Vegetables; Net Weight: 10 lbs. (4.5 kg)/ cs UPC: 00851124006382 Ingredients: Zucchini, Artichoke, ...
Beverages·5,390 affected·Oct 18, 2018
High RiskFDA
Equal Exchange Cooperative Dba Equal Exchange, Inc.
Organic Mind Body and Soul - Breakfast Blend Decaf, packaged in 2.25 oz. pillow packs.
Food·71 affected·Oct 18, 2018
High RiskFDA
Harvest Food Group
Path of Life All Natural Southwest Quinoa; 10oz., 6 and 12 units per case; Keep Frozen; UPC 855229005035; Item# POL-RSWN-1210 and...
Frozen Food·33,528 affected·Oct 18, 2018
High RiskFDA
Harvest Food Group
Zinetti Roasted Vegetable Blend; 40lb. bulk case; Keep Frozen; Item# ZIN-RSVB-0040
Produce·617 affected·Oct 18, 2018
High RiskFDA
Trident Seafoods Corporation
Kroger brand. Frozen non-ready to eat Alaskan Salmon Bites, Net Wt 12 oz (340 g). SKU # 83091. UPC on retail package: 0 11110 83091 3. ...
Seafood·67,518 affected·Oct 18, 2018
High RiskFDA
Harvest Food Group
Signature Select Mexican Style Roasted Corn; 12 oz.; 12/12oz. units per case; Keep Frozen Until Ready To Use; UPC 02113094060; Item...
Frozen Food·82,428 affected·Oct 18, 2018
High RiskFDA
Cadence Gourmet Llc
Cadence Gourmet Cauliflower & Cheese Net Weight: 10 lbs. (4.4 kg) / cs UPC: 00851124006375 Ingredients: Cauliflower, B¿chamel Sauce ...
Dairy·5,650 affected·Oct 18, 2018
High RiskFDA
Cadence Gourmet Llc
Roasted Vegetable Blend; Net Weight: 30 lbs. (12 x 2.5 lb. bags) Corner Bakery Caf¿ Brand Ingredients: Zucchini, artichoke (water, c...
Beverages·299,580 affected·Oct 18, 2018
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Drugs·84 affected·Oct 18, 2018
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., ...
Medical Devices·956,798 affected·Oct 18, 2018
High RiskFDA
Eurotrol Inc
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assaye...
Diagnostic Devices·2,122 affected·Oct 18, 2018