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High RiskFDA
Icu Medical, Inc.
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 ...
Medical Devices·4,790 affected·Aug 31, 2020
CriticalFDA
Roche Diagnostics Operations, Inc.
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Medical Devices·257 affected·Aug 31, 2020
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheter
Surgical Devices·1,680 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Mal...
Medical Devices·1,856,578 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx...
Medical Devices·37,000 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Medical Devices·7 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4....
Medical Devices·88,700 affected·Aug 31, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV mo...
Medical Devices·193 affected·Aug 31, 2020
High RiskFDA
Eagle Family Foods Group Llc
365 Whole Foods Market Organic Reduced fat &Sodium Popcorn, 6 oz. bag, UPC 099482435349, 10 retail units per wholesale case
Snacks & Candy·1,951 affected·Aug 28, 2020
High RiskFDA
Eagle Family Foods Group Llc
365 Everyday Value Organic Classic Salted Popcorn, 6 oz. bag, UPC 099482435332, 10 retail units per wholesale case
Snacks & Candy·360 affected·Aug 28, 2020
High RiskFDA
Eagle Family Foods Group Llc
Nice! Organic White Cheddar Popcorn, 4.5 oz. bag, UPC 049022024946, 12 retail units per wholesale case
Snacks & Candy·80 affected·Aug 28, 2020
High RiskFDA
Eagle Family Foods Group Llc
Cretors Organic Extra Virgin Olive Oil Popcorn, 4.4 oz. bag, UPC 732494001170, 12 retail units per wholesale case
Snacks & Candy·331 affected·Aug 28, 2020
High RiskFDA
Preferred Popcorn
Organic Yellow Popcorn packaged in the following ways: 1) Great Northern Organic Popcorn, Net Wt. 5 Pounds (2.26 Kilograms), UPC 6 107...
Dairy·1,162,117 affected·Aug 28, 2020
High RiskFDA
Eagle Family Foods Group Llc
365 Whole Foods Market Organic White Cheddar Popcorn, 4 oz. bag, UPC 099482428747, 16 retail units per wholesale case
Snacks & Candy·1,316 affected·Aug 28, 2020
High RiskFDA
Eagle Family Foods Group Llc
Nature's Promise Organic Lightly Salted Popcorn, 6 oz. bag, UPC 688267142611, 9 retail units per wholesale case
Snacks & Candy·1,316 affected·Aug 28, 2020
High RiskFDA
Hometown Food Company
Arrowhead Mills Organic Yellow Popcorn, 28oz bag, UPC: 0 7433347665 8, 6 retail bags per wholesale case, case item code 1 7433347665 9
Snacks & Candy·178 affected·Aug 28, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arteri...
Diagnostic Devices·463 affected·Aug 28, 2020
High RiskFDA
Ingredients Solutions Inc.
MBF-202 Carrageenan
Food·18,000 affected·Aug 27, 2020
High RiskFDA
Power Selles Imports Dba Culinary Collective
Blanxart 82% Congo Organic Chocolate Bar. Paper packaging with internal foil wrapper. Net weight per bar: 4.4 oz. UPC 8 32924 00032 9. ...
Dairy·24 affected·Aug 27, 2020
CriticalFDA
Treehouse Foods
Signature Select Chewy Granola Bars, Chocolate Chip, Family Pack, 18 bars, UPC 021130-283637. 18-0.84 oz. Net Wt 15.2 oz (432g) Distrib...
Bakery & Grains·1,202 affected·Aug 27, 2020
High RiskFDA
Shearer's Snacks
Good & Gather Organic Kettle Corn, 7oz pkgs, film bags, 12 individual items per case.
Food·563 affected·Aug 27, 2020
RecallFDA
Roche Diagnostics Operations, Inc.
Albumin Gen.2, Catalog 05166861190
Medical Devices·11,963 affected·Aug 27, 2020
RecallFDA
Roche Diagnostics Operations, Inc.
Tina-quant Complement C4 ver.2, Catalog 05991994190
Medical Devices·180 affected·Aug 27, 2020
High RiskFDA
Lucky Spoon Bakery, Llc
Lucky Spoon Bakery Gluten Free Chocolate Cupcakes with Vanilla Buttercream Frosting, 8.0 oz. plastic clam shell containing 4 cupcakes, UP...
Dairy·523 affected·Aug 26, 2020
High RiskFDA
B&g Foods North America, Inc
Back to Nature, Organic Rosemary and Olive Oil Stoneground Wheat Cracker, 6 oz. foil bag inside paper carton, 6 packages per case .
Bakery & Grains·1,502 affected·Aug 26, 2020
High RiskFDA
Lucky Spoon Bakery, Llc
Lucky Spoon Bakery Gluten Free Fall Frost Pumpkin Cupcake, 8.0 oz. plastic clam shell containing 4 cupcakes, UPC 8-50489-00320-3, P.O. Bo...
Bakery & Grains·47 affected·Aug 26, 2020
High RiskFDA
Lucky Spoon Bakery, Llc
Lucky Spoon Bakery Gluten Free Chewy Chocolatey Brownie Bites, 6.6 oz. plastic clam shell containing approximately 12 (6.6 oz.), UPC 8-50...
Snacks & Candy·134 affected·Aug 26, 2020
High RiskFDA
Lucky Spoon Bakery, Llc
Lucky Spoon Bakery Gluten Free Very Vanilla Cupcakes with Vanilla Buttercream Frosting, 8.0 oz. plastic clam shell containing 4 cupcakes,...
Dairy·416 affected·Aug 26, 2020
High RiskFDA
Lucky Spoon Bakery, Llc
Lucky Spoon Bakery Gluten Free Chocolate Celebration Cake, 17.5 oz. plastic clam shell containing 1 cake, UPC 8-50489-00322-7, P.O. Box 2...
Bakery & Grains·407 affected·Aug 26, 2020
High RiskFDA
Lucky Spoon Bakery, Llc
Lucky Spoon Bakery Gluten Free Frosty Zucchini Cupcakes, 8.0 oz. plastic clam shell containing 4 cupcakes, UPC 8-50489-00311-1, P.O. Box ...
Bakery & Grains·49 affected·Aug 26, 2020
High RiskFDA
Ev3 Inc.
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Surgical Devices·4,286 affected·Aug 26, 2020
High RiskFDA
Wright Medical Technology Inc
EVOLVE STEM 8.5MM Model # 496S085
Medical Devices·16 affected·Aug 26, 2020
High RiskFDA
Keurig Dr Pepper, Inc.
Newman's Own Organics, Newman's Special Decaf Medium Roast, Ground Coffee, 10 oz.
Beverages·7,050 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets, NDC 64727-5750-4...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) ...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) ...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Asiaticon, Sa De Cv
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499...
Topical Drugs·111,500 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, packaged in a) 30-...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-coun...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-co...
Oral Drugs·0 affected·Aug 25, 2020
CriticalFDA
Rlc Labs Inc.
Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, ...
Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) ...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets, NDC 64727-5950-4...
Oral Drugs·0 affected·Aug 25, 2020
CriticalFDA
Rlc Labs Inc.
Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (...
Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tablets, NDC 64727-6...
Oral Drugs·0 affected·Aug 25, 2020
High RiskFDA
Rlc Labs Inc.
Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bott...
Oral Drugs·0 affected·Aug 25, 2020
CriticalFDA
Rlc Labs Inc.
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-cou...
Drugs·0 affected·Aug 25, 2020