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High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottl...
Oral Drugs·0 affected·Sep 2, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets,...
Oral Drugs·0 affected·Sep 2, 2020
High RiskFDA
Charles Paint Research Inc
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 g...
Topical Drugs·600 affected·Sep 2, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottle...
Drugs·0 affected·Sep 2, 2020
High RiskFDA
Charles Paint Research Inc
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 g...
Topical Drugs·3,900 affected·Sep 2, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tabl...
Oral Drugs·0 affected·Sep 2, 2020
High RiskFDA
Ph-d Feminine Health
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, ...
Drugs·37,000 affected·Sep 2, 2020
High RiskFDA
Biomet, Inc.
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage...
Medical Implants·3 affected·Sep 2, 2020
High RiskFDA
Gentian As
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012,...
Medical Devices·107 affected·Sep 2, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and ...
Medical Devices·15 affected·Sep 1, 2020
High RiskFDA
Medline Industries Inc
ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal...
Surgical Devices·6,225 affected·Sep 1, 2020
High RiskFDA
Fresco Foods
Ancient Grain Jackfruit Bowl with Chickpeas & Edamame in a Thai Coconut Sauce, Eat Fresco, Keep Refrigerated, NET WT 14oz (397gr), Cook T...
Produce·1,096 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3...
Medical Devices·231,250 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Medical Devices·2,900 affected·Aug 31, 2020
High RiskFDA
Brainlab Ag
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: inten...
Medical Devices·271 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spir...
Medical Devices·19,850 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Dri...
Medical Devices·217,522 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Medical Devices·2 affected·Aug 31, 2020
High RiskFDA
Encore Medical, Lp
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shou...
Surgical Devices·15 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Medical Devices·325 affected·Aug 31, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Us...
Surgical Devices·5,813 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Medical Devices·10 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip ...
Medical Devices·55,000 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
Medical Devices·9 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
Medical Devices·900 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Medical Devices·35 affected·Aug 31, 2020
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
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
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
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