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CriticalFDA
Cme America, Llc
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
Medical Devices·198,160 affected·Jun 16, 2020
CriticalFDA
Cme America, Llc
BodyGuard Microset, REF: A120-160XPS
Medical Devices·479,559 affected·Jun 16, 2020
CriticalFDA
Now Health Group Inc.
NOW Real Food Raw Macadamia Nuts Unsalted 8 oz retail bag UPC 733739071194 Item number 7119
Food·4,251 affected·Jun 12, 2020
CriticalFDA
Rong Shing Trading Ny Inc
Xi Zhi Liang Fruit Jelly Cups; 21.1oz (600g); packaged in pink, yellow, and blue plastic backpacks with numerous individual plastic jelly...
Produce·65 affected·Jun 11, 2020
CriticalFDA
Masterpharm Llc
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room tem...
Oral Drugs·300 affected·Jun 9, 2020
CriticalFDA
Verathon, Inc.
GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core One...
Medical Devices·437 affected·Jun 5, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharet...
Oral Drugs·29,304 affected·May 22, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alphar...
Oral Drugs·112,140 affected·May 22, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Al...
Oral Drugs·49,128 affected·May 22, 2020
CriticalFDA
Captain Rusty's Seafood Products Llc
Captain Rusty's Smoked Mahi Dip, Made with real Mahi meat, Keep Refrigerated, 6 lb.
Meat & Poultry·0 affected·May 21, 2020
CriticalFDA
Captain Rusty's Seafood Products Llc
Captain Rusty's Blue Crab Dip, Made with real Blue Crab meat, Keep Refrigerated,16 oz.
Meat & Poultry·0 affected·May 21, 2020
CriticalFDA
Captain Rusty's Seafood Products Llc
Captain Rusty's Cajun Crab & Lobster Dip, Made with real Blue Crab and Lobster meat, Keep Refrigerated,16 oz.
Meat & Poultry·0 affected·May 21, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Bake'n Joy Foods, Inc.
Sienna brand 4.25 oz. Cranberry Orange Muffins coded 20 071 31B
Produce·48 affected·May 19, 2020
CriticalFDA
Ventura Foods Llc
Garlic Sauce; Net Wt. 8LB. (3.62 kg); PJ Item #1104; UPC 26700 16345; Manufactured for: PJ Foods Service, Inc; Louisville, KY 40299, USA....
Beverages·1,876 affected·May 14, 2020
CriticalFDA
New Hoque & Sons, Inc.
"Radhuni Curry Powder, 400 grams (14.11 oz.)***Ingredients: Coriander, Tumeric, Chili, Bitsalt, Aniseed, Sodium Chloride, Garlic, Cumin, ...
Food·33 affected·May 14, 2020
CriticalFDA
Ramar International Corporation
Peekaboo Ice Cream + hidden Veggies; Organic Mint Chocolate Chip with Hidden Spinach, 14 oz. carton: UPC: 868540000115 Manufactured...
Dairy·255 affected·May 12, 2020
CriticalFDA
Medtronic Vascular Galway Dba Medtronic Ireland
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Surgical Devices·103 affected·May 12, 2020
CriticalFDA
K F K Seasonings Llc
Organic Ground Oregano, Item # 90206. Packaged in 40 lbs. or 50 lbs. cases and sold under brand KFK Seasoning. This product contains Or...
Food·500 affected·May 8, 2020
CriticalFDA
K F K Seasonings Llc
Chili Powder, Mild, Organic is a blend, Item # 90030. Packaged in 1 lb. bags and sold under brand Azure Market. This product contains "...
Food·96 affected·May 8, 2020
CriticalFDA
Icu Medical Inc
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Injectable Drugs·93,648 affected·May 8, 2020
CriticalFDA
Endologix, Inc.
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I,...
Medical Implants·9,156 affected·May 6, 2020
CriticalFDA
Mondelez Global Llc
RITZ Cheese Cracker Sandwiches , Family Size , (21.6 oz. carton)
Dairy·9,110 affected·May 1, 2020
CriticalFDA
Jason Pharmaceuticals, Inc. T/a Medifast
Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 oz./ 32 g pouch, Multi-layer Kraft paper/aluminum pouches, Seven pouches per c...
Food·24,923 affected·May 1, 2020
CriticalFDA
Condies Foods, Inc.
43559 SNDW Chicken Sandwich on White Single, vacuumed pack bag, Clam shell. Label UPC: 50777444804, Condies Foods Inc. PO Box 18548. Sa...
Meat & Poultry·61 affected·Apr 27, 2020
CriticalFDA
Condies Foods, Inc.
43237 ROLL chicken salad on croissant single, vacuumed pack bag, Clam shell. Label UPC: 50777445351, Condies Foods Inc. PO Box 18548. ...
Meat & Poultry·104 affected·Apr 27, 2020
CriticalFDA
Royal International Trading Inc.
TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE; Assorted dried fruits; NET WT 17.63 oz (500g) clear plastic package
Produce·30 affected·Apr 22, 2020
CriticalFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials p...
Injectable Drugs·5,314,400 affected·Apr 20, 2020
CriticalFDA
Mellace Family Brands California Inc
Wegmans brand Semi-Sweet Chocolate Nonpareils in an 18.5 oz. (524 g) plastic container, 12 plastic containers per case.
Snacks & Candy·294 affected·Apr 18, 2020
CriticalFDA
B. Braun Medical Inc
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 1...
Injectable Drugs·22,488 affected·Apr 18, 2020
CriticalFDA
Whole Foods Market
Whole Foods Market Queso Sauce PLU code printed on the product scale labels beginning with 74135 sold in clear plastic deli-style contain...
Food·9 affected·Apr 16, 2020
CriticalFDA
Summitt Labs
KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.81...
Drugs·236 affected·Apr 15, 2020
CriticalFDA
Masterpharm Llc
Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty ...
Oral Drugs·7,260 affected·Apr 14, 2020
CriticalFDA
Whole Foods Market
Whole Foods Market Minestrone Soup PLU code printed on the product scale labels beginning with 248529 for soup sold in clear plastic deli...
Food·1,615 affected·Apr 10, 2020
CriticalFDA
Champlain Chocolate Company
Lake Champlain CHOCOLATES, COIN DARK BULK ORG, NET WT 48 OZ (1.3 kg), APPROX 186 PIECES, INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LI...
Dairy·9 affected·Apr 10, 2020
CriticalFDA
Medtronic Inc.
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Medical Implants·24 affected·Apr 10, 2020
CriticalFDA
H & C Food Inc.
Enoki Mushroom; 7.5oz (200g); UPC #831211204181; packed in clear plastic bag with green label; imported from Green Co. located in Korea; ...
Food·2,500 affected·Apr 7, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Medical Implants·2,614 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Cardiac Devices·20,147 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Medical Implants·2,225 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Medical Implants·85 affected·Apr 3, 2020
CriticalFDA
Min Jiang Food Store Inc Dba Koi Koi Trading
Fresh Salmon; Brand names : Bakka, Superior, Scottish Canada, Ocean Quality, Norway. Refrigerate Unit size: 10-12 lbs., 14-16 lbs., 16...
Seafood·2,787 affected·Mar 26, 2020
CriticalFDA
Avet Pharmaceuticals, Inc.
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 088...
Oral Drugs·17,524 affected·Mar 23, 2020