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High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Jalapeno-Ranch White Cheddar cheese curds, Net Wt. 12 oz, UPC 094922414984
Dairy·48 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Orange Pineapple ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·18 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, White Chocolate Raspberry ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·72 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Chocolate Malt ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·72 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Bacon-Ranch White Cheddar cheese curds, Net Wt. 12 oz, UPC 094922414984
Dairy·24 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Taco White Cheddar cheese curds, Net Wt. 12 oz, UPC 094922414984
Dairy·24 affected·Sep 15, 2021
High RiskFDA
American Health Packaging
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health ...
Oral Drugs·548 affected·Sep 15, 2021
High RiskFDA
Seviroli Foodsvertullo Imports
HEB Jumbo Stuffed Shells; Jumbo Shells Filled with Creamy Ricotta and Romano Cheese; NET WT. 22 OZ (1 LB 6OZ) 624g
Dairy·1,349 affected·Sep 14, 2021
High RiskFDA
Direct Rx
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceutic...
Oral Drugs·2 affected·Sep 14, 2021
High RiskFDA
Buurma Farms Inc
Buurma Farms Plain Parsley (Flat Parsley) PLU twist tie or banded bunches 30ct in cardboard cartons 60ct in wooden crates
Food·315 affected·Sep 13, 2021
High RiskFDA
The Enrico Biscotti Company
Enrico Biscotti - Cranberry Pistachio Biscotti 8 ounce bags 6 bags per case
Produce·3,840 affected·Sep 13, 2021
High RiskFDA
The Enrico Biscotti Company
Enrico Biscotti - Anise Almond Biscotti 8 ounce bags 6 bags per case
Food·3,840 affected·Sep 13, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit,...
Medical Devices·168 affected·Sep 13, 2021
High RiskFDA
Sspi Mid-atlantic, Inc
1. Dickies Seafood Cooked & Spiced Shrimp (12 oz) UPC 5240700804 Sell by 9/8/2021 & 9/12/2021. Labeled containers 2. Dickies Seafood C...
Seafood·1,746 affected·Sep 10, 2021
High RiskFDA
Mckee Foods Corporation
Little Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies 2.5oz plastic packaging 72 pouches per case
Bakery & Grains·1,800 affected·Sep 10, 2021
High RiskFDA
Piramal Critical Care, Inc.
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, ...
Injectable Drugs·100 affected·Sep 10, 2021
High RiskFDA
Karl Storz Endoscopy
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Medical Devices·532 affected·Sep 10, 2021
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Foundation Kit
Medical Devices·790 affected·Sep 10, 2021
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
IUD Insertion Pack
Medical Devices·20 affected·Sep 10, 2021
High RiskFDA
Draeger Medical, Inc.
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) u...
Respiratory Devices·2,169 affected·Sep 10, 2021
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
IUD Insertion Kit
Medical Devices·14,959 affected·Sep 10, 2021
High RiskFDA
Kinsman Enterprises Inc
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Medical Devices·13,123 affected·Sep 10, 2021
High RiskFDA
Inpeco S.a.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Medical Devices·262 affected·Sep 10, 2021
High RiskFDA
Jag Specialty Foods, Llc
Daniele - PLAIN BULK (28 LB.); Plain Breadsticks; Case Pack 4/7lb bags; Item #1383; PLAIN: UNBLEACHED ENRICHED WHEAT FLOUR (CONTAINS MALT...
Bakery & Grains·10,000 affected·Sep 9, 2021
High RiskFDA
Dole Fresh Vegetables Inc
Bunches of curly parsley packed in cardboard cases received at distributor level with following labeling: Herb Parsley Curly Grown in Sa...
Produce·113 affected·Sep 9, 2021
High RiskFDA
Brainmd
Brain MD - Brain & Memory Power Boost Supports Healthy Brain and Memory Performance 120 capsules - Dietary Supplement UPC: 8 57568 00341...
Produce·1,765 affected·Sep 9, 2021
High RiskFDA
Vi-jon, Inc.
Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-...
Drugs·21,156 affected·Sep 9, 2021
High RiskFDA
Aurobindo Pharma Usa Inc.
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Ro...
Oral Drugs·2,820 affected·Sep 9, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
C315-HIS Delivery Catheter
Surgical Devices·591 affected·Sep 9, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Medical Devices·10 affected·Sep 9, 2021
High RiskFDA
Seabear Company
Banquet Cut European Style Cold Smoked Salmon, Item Number 2-92845, brand Gerard and Dominique Seafoods, packaged in pouch, net wt. per p...
Seafood·126 affected·Sep 8, 2021
High RiskFDA
Akorn, Inc.
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A...
Ophthalmic Drugs·62,331 affected·Sep 8, 2021
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-0...
Medical Devices·3,969 affected·Sep 8, 2021
High RiskFDA
Fujifilm Irvine Scientific, Inc.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (...
Medical Devices·3,981 affected·Sep 8, 2021
High RiskFDA
K2m, Inc
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Medical Devices·23 affected·Sep 8, 2021
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-0...
Medical Devices·5,054 affected·Sep 8, 2021
High RiskFDA
Medical Action Industries, Inc. 306
Kit: Central Line Dres Change 20/Cs
Medical Devices·42 affected·Sep 8, 2021
High RiskFDA
Baker's Corner Bakery
Oatmeal Cranberry Cookie, packed in closed bags, 12oz net wt. The label of affected product is read in parts: "***Oatmeal Cranberry Cook...
Bakery & Grains·29 affected·Sep 7, 2021
High RiskFDA
Baker's Corner Bakery
Lemon Thyme Cookies, packed in closed bags, 12oz net wt. The label of affected product is read in parts: "***Lemon Thyme Cookies*** Ingr...
Bakery & Grains·27 affected·Sep 7, 2021
High RiskFDA
Baker's Corner Bakery
Oatmeal Butterscotch Cookie, packed in closed bags, 12oz net wt. The label of the affected product is read in parts: "***Oatmeal Butters...
Dairy·33 affected·Sep 7, 2021
High RiskFDA
De Wafelbakkers, Llc
De Wafelbakkers 18 ct Buttermilk Pancakes NET WT 1 lb. 8.7 oz. (703g) KEEP FROZEN packaged in clear flexible plastic UPC 679844104573
Dairy·200 affected·Sep 7, 2021
High RiskFDA
Baker's Corner Bakery
Chocolate Chip Cookie, packed in closed bags, 12oz net wt. The label of affected label is read in parts: "***Chocolate Chip Cookie***Ing...
Bakery & Grains·36 affected·Sep 7, 2021
High RiskFDA
Baker's Corner Bakery
Lemon Blueberry Scones, packed in closed box, net wt. 12 oz. The label of affected product is read in parts: "*** Lemon Blueberry Scones...
Dairy·12 affected·Sep 7, 2021
High RiskFDA
Nox Medical
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Medical Devices·128 affected·Sep 7, 2021
High RiskFDA
W L Gore & Associates, Inc.
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent ...
Medical Implants·2 affected·Sep 7, 2021
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Onl...
Oral Drugs·14,904 affected·Sep 3, 2021
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; M...
Oral Drugs·38,748 affected·Sep 3, 2021
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA...
Drugs·116,400 affected·Sep 3, 2021