Skip to main content
CriticalFDA
Working Cow Homemade Inc.
Toaste Coconut with Chocolate Ice Cream, 3 gallons
Dairy·365 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
Superman Ice Cream, 3 gallons
Dairy·4,560 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
No Sugar Added Mint Swirl Ice Cream, 3 gallons
Dairy·723 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
JY Cherry Cordial Ice Cream, 3 gallons
Dairy·9 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
JY Raspberry Tracks Ice Cream, 3 gallons
Dairy·46 affected·Sep 28, 2018
CriticalFDA
La Mexicana Llc
La Mexicana Cantina Salsa 14 oz., 24 oz., and 64 oz.
Food·780,000 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
Guava Ice Cream, 3 gallons
Dairy·43 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
Toffee Butter Pecan Ice Cream, 3 gallons
Dairy·34 affected·Sep 28, 2018
CriticalFDA
Medtronic Navigation, Inc.
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedu...
Medical Devices·5,487 affected·Sep 26, 2018
CriticalFDA
Oscor, Inc.
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packa...
Cardiac Devices·36,688 affected·Sep 26, 2018
CriticalFDA
Lloyd's Ice Cream Inc
Lic's REESE'S OREO, ONE QUART (946 mL), packed in Plastic quart container
Food·571 affected·Sep 21, 2018
CriticalFDA
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Medical Devices·0 affected·Sep 20, 2018
CriticalFDA
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Medical Devices·0 affected·Sep 20, 2018
CriticalFDA
Purus Labs, Inc.
Purus Labs MYOWHEY Premium Whey Protein, Chocolate Cookie Crunch, 75 True Servings, Net Wt. 5 lb / 2.26 kg. UPC 55734-00285. Manufactur...
Bakery & Grains·1,280 affected·Sep 18, 2018
CriticalFDA
Covidien Llc
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilat...
Respiratory Devices·9,593 affected·Sep 18, 2018
CriticalFDA
Endo Pharmaceuticals, Inc.
robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 1935...
Oral Drugs·2,856 affected·Sep 17, 2018
CriticalFDA
Leica Microsystems, Inc.
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Medical Devices·876 affected·Sep 17, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MC
Medical Devices·18 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Medical Devices·1,166 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Medical Devices·276 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of...
Cardiac Devices·103 affected·Sep 14, 2018
CriticalFDA
Roche Diagnostics Corporation
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strip...
Medical Devices·1,163,952 affected·Sep 13, 2018
CriticalFDA
Mccormick & Company, Inc. - Flavor Manufacturing Center
Meijer Taco Seasoning Mix, Net wt. 4.5 oz.
Food·728 affected·Sep 10, 2018
CriticalFDA
Market Of Choice Inc
Sesame Noodle Salad Vegan, packaged in 8 oz. or 16 oz. plastic container. UPC of 8 oz. container: 0 211630 203994. UPC of 16 oz. co...
Beverages·559 affected·Sep 7, 2018
CriticalFDA
Gravel Ridge Farms
Shelled eggs in blank cardboard cases at 2.5 dozen a case. Shelled eggs in dozen cartons labeled as "Gravel Ridge Farms Cullman County...
Food·55,000 affected·Sep 7, 2018
CriticalFDA
Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer...
Medical Devices·1 affected·Sep 6, 2018
CriticalFDA
Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer i...
Medical Devices·821 affected·Sep 6, 2018
CriticalFDA
Elaboraciones Felo, Inc.
Super Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
Food·29,133 affected·Sep 5, 2018
CriticalFDA
Elaboraciones Felo, Inc.
Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
Food·7,011 affected·Sep 5, 2018
CriticalFDA
Elaboraciones Felo, Inc.
Square Shell for Turnovers, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
Food·76 affected·Sep 5, 2018
CriticalFDA
H & C Food Inc.
Fish Balls, packaged in a red and white plastic bag with gold font, NET WT: 14OZ (400g), UPC: 6 953006 4 50093. Keep Frozen.
Seafood·0 affected·Sep 4, 2018
CriticalFDA
H & C Food Inc.
Fuzhou Fish Balls, packaged in a blue and white package bag, in two sizes: Net WT: 14 OZ (400g), UPC: 6 953640 05000 and Net WT:4.5 lbs...
Seafood·0 affected·Sep 4, 2018
CriticalFDA
Alpha Omega Engineering
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelec...
Surgical Devices·29 affected·Sep 4, 2018
CriticalFDA
Data Innovations, Llc
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer...
Medical Devices·9 affected·Aug 29, 2018
CriticalFDA
Alcon Research, Ltd.
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Medical Implants·30,561 affected·Aug 28, 2018
CriticalFDA
Alcon Research, Ltd.
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Medical Implants·14,264 affected·Aug 28, 2018
CriticalFDA
Sca Pharmaceuticals, Inc.
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Kn...
Injectable Drugs·1,384 affected·Aug 27, 2018
CriticalFDA
Quva Pharma, Inc.
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 088...
Drugs·528 affected·Aug 27, 2018
CriticalFDA
Hellolife
Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. ND...
Drugs·1,869 affected·Aug 23, 2018
CriticalFDA
Hellolife
Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. ND...
Drugs·989 affected·Aug 23, 2018
CriticalFDA
Hellolife
Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. ND...
Drugs·4,358 affected·Aug 23, 2018
CriticalFDA
Hellolife
Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. ND...
Drugs·370 affected·Aug 23, 2018
CriticalFDA
Accord Healthcare, Inc.
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufac...
Oral Drugs·46,632 affected·Aug 21, 2018
CriticalFDA
Air Stream Corp.
Salad Mix (Endive, Chicory, Romaine, Escarole, and Radicchio)
Produce·887 affected·Aug 18, 2018
CriticalFDA
Hidroponicos Brownia, S.p.r. De R.l.
Aztlan Mole Oaxaqueno Negro; 10 kg plastic buckets (22 lbs); Ingredients: sugar, Ancho pepper, peanut, soybean oil, pasilla pepper, ...
Bakery & Grains·450 affected·Aug 17, 2018
CriticalFDA
Hidroponicos Brownia, S.p.r. De R.l.
Aztlan Mole Poblano; 10 kg plastic buckets (22 lbs); Ingredients: sugar, Ancho pepper, peanut, soybean oil, pasilla pepper, guajillo...
Bakery & Grains·650 affected·Aug 17, 2018
CriticalFDA
Neighbors Llc
Crazy About Cookies***GLUTEN FREE CHOCOLATE CHIP COOKIE DOUGH**Net Wt. 2 lbs. (907.18g)**Nutrition facts***Ingredients: Whole grain sorgh...
Dairy·7,264 affected·Aug 17, 2018
CriticalFDA
Marsee Foods Inc
Chocolate Chip Cookies, brand Cafe YUMM! Product is packaged in shrink wrapped master case. Each master case contains two boxes and eac...
Bakery & Grains·96 affected·Aug 15, 2018