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CriticalFDA
Berlin Heart Gmbh
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (2...
Medical Devices·335 affected·May 18, 2018
CriticalFDA
Qiagen Sciences, Inc.
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, no...
Medical Devices·1,620 affected·May 18, 2018
CriticalFDA
Ziyad Brothers Importing, Inc.
Ziyad Brand Tahini, 8oz, 16oz, ¿ gal, 32oz. , packed in glass jars
Food·655 affected·May 17, 2018
CriticalFDA
Shoreside Enterprises Inc.
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Oral Drugs·0 affected·May 17, 2018
CriticalFDA
Shoreside Enterprises Inc.
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA,...
Drugs·0 affected·May 17, 2018
CriticalFDA
Intuitive Surgical, Inc.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Surgical Devices·1 affected·May 17, 2018
CriticalFDA
Blm Products U. Vertriebsges
Priano Rosso Pesto Sauce, 6.7oz glass jar
Food·174,636 affected·May 15, 2018
CriticalFDA
Draeger Medical Systems, Inc.
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervisio...
Medical Devices·10,363 affected·May 15, 2018
CriticalFDA
Draeger Medical Systems, Inc.
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision...
Medical Devices·6,711 affected·May 15, 2018
CriticalFDA
Caudill Sprouting Llc
Alfalfa Seeds
Food·0 affected·May 10, 2018
CriticalFDA
Konica Minolta Medical Imaging Usa, Inc.
CS-7, Model No. A4C1
Medical Devices·0 affected·May 9, 2018
CriticalFDA
Konica Minolta Medical Imaging Usa, Inc.
ImagePilot, Model No. D9MA
Medical Devices·0 affected·May 9, 2018
CriticalFDA
Apotex Inc.
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare ...
Injectable Drugs·13,453 affected·May 8, 2018
CriticalFDA
Apotex Inc.
Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcar...
Injectable Drugs·121,693 affected·May 8, 2018
CriticalFDA
Vyaire Medical
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b....
Respiratory Devices·15,714 affected·May 8, 2018
CriticalFDA
Vyaire Medical
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief va...
Respiratory Devices·15,714 affected·May 8, 2018
CriticalFDA
Morgan Foods, Inc.
Great Value Gluten Free Tomato Condensed Soup, 10.5 oz, Number 1 Can, Two formats shipped: 8 cans per tray and 12 cans per tray
Produce·121,992 affected·May 7, 2018
CriticalFDA
Biosense Webster, Inc.
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Medical Devices·25 affected·May 7, 2018
CriticalFDA
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-080...
Medical Devices·4,300 affected·May 3, 2018
CriticalFDA
Badger Botanicals Llc
Acadica Kratom: Green Suma, 250g bags
Food·0 affected·May 2, 2018
CriticalFDA
Utz Quality Food Inc
Utz Restaurant Style Tortilla Chips; Net Wt 17 oz; White Corn Tortilla Chips; UPC: 0-41780-00383-6; Exp. Date Jun 16 18; UTZ Quality Food...
Snacks & Candy·92,553 affected·May 2, 2018
CriticalFDA
Flowers Bakery Of Montgomery Llc
Hot Dog Buns
Food·155 affected·May 2, 2018
CriticalFDA
Utz Quality Food Inc
Utz Organic Yellow Corn Tortillas, Net Wt 9 oz; UTZ Quality Foods, Inc., Hanover, PA 17331; UPC: 0-41780-01337-8; Exp date: MAY 26 18 to...
Food·22,281 affected·May 2, 2018
CriticalFDA
Badger Botanicals Llc
Acadica Kratom: Red Suma 250g bags
Food·0 affected·May 2, 2018
CriticalFDA
Utz Quality Food Inc
Weis Signature Collection No Salt Added White Corn Tortilla Chips; Net Wt 11 oz; Manufactured For Weis Markets, Sunbury, PA 17801; UPC: ...
Snacks & Candy·2,370 affected·May 2, 2018
CriticalFDA
Flowers Bakery Of Montgomery Llc
French Toast Bread
Bakery & Grains·924 affected·May 2, 2018
CriticalFDA
Utz Quality Food Inc
Golden Flake TORTIYAHS! Superior Dipping Chips; Net Wt 12.5 oz Tortilla Chips; Golden Flake Snack Foods, Inc. Birmingham, AL 35201; UPC: ...
Snacks & Candy·55,332 affected·May 2, 2018
CriticalFDA
Utz Quality Food Inc
Utz Organic Blue Corn Tortillas; Net Wt 9 oz; UTZ Quality Foods, Inc., Hanover, PA 17331; UPC: 0-41780-01317-0; Exp date: JUN 16 18;
Food·41,935 affected·May 2, 2018
CriticalFDA
Badger Botanicals Llc
Acadica Kratom: Green Hulu 2 Kratom, 250g bags
Food·0 affected·May 2, 2018
CriticalFDA
Utz Quality Food Inc
Good Health Organic Tortillas; Black Bean & Rice; Net Wt 5.5 oz; Distributed by Good Health Natural Products, Inc. Greensboro, NC; UPC: 2...
Food·5 affected·May 2, 2018
CriticalFDA
Badger Botanicals Llc
Acadica Kratom: Red Hulu 2, 250g bags
Food·0 affected·May 2, 2018
CriticalFDA
The Seaberg Company Inc
Part #: SAM XT-M, Model: Tactical Black or Military
Medical Devices·0 affected·May 2, 2018
CriticalFDA
The Seaberg Company Inc
Part #: SAM XT-C, Model: Hi-Viz Blue
Medical Devices·0 affected·May 2, 2018
CriticalFDA
Heartware
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 140...
Cardiac Devices·175,878 affected·May 2, 2018
CriticalFDA
Auromedics Pharma Llc
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics P...
Injectable Drugs·54,720 affected·May 1, 2018
CriticalFDA
Auromedics Pharma Llc
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured fo...
Injectable Drugs·77,400 affected·May 1, 2018
CriticalFDA
Stonewall Kitchen, Llc
STONEWALL KITCHEN Basil Pesto Aioli Net Weight Net 10.25 oz. UPC: 7 11381 03060 8. Product is incorrectly labeled as Basil Pesto, Net Wei...
Food·732 affected·Apr 30, 2018
CriticalFDA
Ethnic Foods, Inc. D/b/a Bombay Kitchen Foods
Bombay Kitchen Bhavnagri Mix, packaged in a 19 oz., clear bag, UPC: 808550110206
Food·134 affected·Apr 26, 2018
CriticalFDA
Greenbelt Greenhouse Ltd
Fresh Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 9...
Food·486 affected·Apr 24, 2018
CriticalFDA
Greenbelt Greenhouse Ltd
Spicy Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 9...
Food·390 affected·Apr 24, 2018
CriticalFDA
Greenbelt Greenhouse Ltd
Sunflower Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 ...
Food·474 affected·Apr 24, 2018
CriticalFDA
Labrada Nutrition, Inc
Lean Pro 8 Chocolate 2,268g (5lb) Tub and Lean Pro 8 Chocolate 1,000g (2.2lb) Tub
Snacks & Candy·2,976 affected·Apr 24, 2018
CriticalFDA
Greenbelt Greenhouse Ltd
Pea Shoots Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8...
Food·546 affected·Apr 24, 2018
CriticalFDA
Labrada Nutrition, Inc
Lean Pro 8 Cookies & Cream 1,000g (2.2lb) Tub
Dairy·132 affected·Apr 24, 2018
CriticalFDA
Labrada Nutrition, Inc
Lean Pro 8 Vanilla 2,268g (5lb) Tub
Food·3,517 affected·Apr 24, 2018
CriticalFDA
Greenbelt Greenhouse Ltd
Arugula Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90...
Food·498 affected·Apr 24, 2018
CriticalFDA
Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
Medical Devices·6,816 affected·Apr 23, 2018
CriticalFDA
Eden's Ethnos, Llc
Eden's Ethnos Bulk Kratom 25 powder kilogram bag Also called K. Bali Supreme, K Maeng Da Supreme, K Green Vein, Green Maeng Da, K Red M...
Food·2,775 affected·Apr 20, 2018