Skip to main content
High RiskFDA
Roche Diagnostics Corporation
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tin...
Diagnostic Devices·656 affected·Dec 14, 2018
High RiskFDA
Madison Polymeric Engineering
Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydr...
Surgical Devices·4,800 affected·Dec 14, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Trigly...
Diagnostic Devices·137 affected·Dec 14, 2018
CriticalFDA
Adam Bros. Farming, Inc.
Adam Bros. Family Farms Cauliflower; Sold in cases with 9, 12, 16 or 20 count cases
Food·5 affected·Dec 13, 2018
CriticalFDA
Adam Bros. Farming, Inc.
Adam Bros. Family Farms Red Leaf Lettuce 24 heads per carton Adams Bros Family Farms and Ovation
Produce·2,970 affected·Dec 13, 2018
High RiskFDA
Gertrude Hawk Brands Dba Gertrude Hawk Chocolates
R.H. Macy & Co. Milk Chocolate Butter Almond Toffee, 6 oz. 1 unit per package, oval metal tin canister, 6 units per case,
Dairy·11,250 affected·Dec 13, 2018
High RiskFDA
Gertrude Hawk Brands Dba Gertrude Hawk Chocolates
R.H. Macy & Co. Dark Chocolate Sea Salt Caramels, 7 oz. 1 unit per package, oval metal tin canister, 6 units per case,
Snacks & Candy·8,304 affected·Dec 13, 2018
High RiskFDA
The Secret Garden Of Park Rapids, Inc.
Barley Lentil Dry soup base. UPC 91675-06002. the Secret Garden, Park Rapids, MN 56470
Food·6 affected·Dec 13, 2018
High RiskFDA
Gertrude Hawk Brands Dba Gertrude Hawk Chocolates
R.H. Macy & Co. Milk Chocolate Covered Pecan Caramel Clusters, 7oz 1 unit per package, oval metal tin canister, 6 units per case
Dairy·10,848 affected·Dec 13, 2018
CriticalFDA
Adam Bros. Farming, Inc.
Adam Bros. Family Farms Green Leaf Lettuce; 24 heads per case
Produce·3,448 affected·Dec 13, 2018
High RiskFDA
Prothera, Inc. Dba Sfi Usa
Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9
Food·139 affected·Dec 13, 2018
High RiskFDA
Gertrude Hawk Brands Dba Gertrude Hawk Chocolates
R.H. Macy & Co. Milk Chocolate Covered Peanut Butter Pretzels, 8 oz 1 unit per package, oval metal tin canister, 6 units per case
Dairy·5,178 affected·Dec 13, 2018
High RiskFDA
Elekta, Inc.
MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment plan...
Medical Devices·3,950 affected·Dec 13, 2018
High RiskFDA
Arrow International Inc
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is in...
Medical Devices·963 affected·Dec 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK 2 AST-N351 Test Kit
Diagnostic Devices·30,292 affected·Dec 13, 2018
RecallFDA
Fish House Dressing, Inc.
Jimmy's Original Blue Cheese Salad Dressing 15 Fl. Oz (443 ml). UPC 86824-22345 Keep Refrigerated. Manufactured by: Fish House Dress...
Dairy·1,741 affected·Dec 12, 2018
High RiskFDA
Ion Beam Applications S.a.
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device de...
Medical Devices·7 affected·Dec 12, 2018
High RiskFDA
Dahlicious
DAHlicious ORGANIC Lassi India -Style DRINKABLE YOGURT, Grassland Plain, , 32 FL OZ (946 mL), UPC: 7 93573 01459 7
Dairy·2,175 affected·Dec 11, 2018
CriticalFDA
Lipari Foods Operating Company, Llc
Inspired Organic Tahini Butter 16oz. plastic jar, 6 per case UPC #: 863669742564 refrigerate after opening
Dairy·925 affected·Dec 11, 2018
CriticalFDA
Lipari Foods Operating Company, Llc
Inspired Organic Peanut Butter 16oz. plastic jar, 6 per case UPC #: 863669742588 refrigerate after opening
Dairy·1,739 affected·Dec 11, 2018
High RiskFDA
Dahlicious
DAHlicious ORGANIC LASSI India-Style DRINKABLE YOGURT Golden Turmeric Lassi, 23 FL OZ (946 mL), UPC: 7 93573 01476 4.
Dairy·1,296 affected·Dec 11, 2018
CriticalFDA
Lipari Foods Operating Company, Llc
Inspired Organic Almond Butter 16oz. plastic jar, 6 per case UPC #: 863669742540 refrigerate after opening
Dairy·1,309 affected·Dec 11, 2018
CriticalFDA
Moonstruck Chocolate Company
Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck brand. The product sold in an individual resealable plastic bag, net wt. 4 oz....
Dairy·600 affected·Dec 11, 2018
High RiskFDA
Del Monte Research Center - Walnut Creek
Del Monte Quality Fresh Cut Harvest Selects Fiesta Corn seasoned with Red & Green Peppers. NET WT 15.25 oz. (432 g); UPC 0 24000 02770;...
Beverages·64,242 affected·Dec 11, 2018
CriticalFDA
Lipari Foods Operating Company, Llc
Inspired Organic Sunflower Butter 16oz. plastic jar, 6 per case UPC #: 863669742526 refrigerate after opening
Dairy·972 affected·Dec 11, 2018
CriticalFDA
Asclemed Usa Inc. Dba Enovachem
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
Injectable Drugs·0 affected·Dec 11, 2018
CriticalFDA
Asclemed Usa Inc. Dba Enovachem
Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
Injectable Drugs·0 affected·Dec 11, 2018
High RiskFDA
Kvk-tech, Inc.
Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50
Oral Drugs·156 affected·Dec 11, 2018
High RiskFDA
Kimberly-clark Corporation
U by Kotex¿ Sleek¿, Regular Tampons, 3 Count
Medical Devices·68,852,076 affected·Dec 11, 2018
High RiskFDA
Kimberly-clark Corporation
U by Kotex¿ Sleek¿, Regular Tampons, 18 Count
Medical Devices·68,852,076 affected·Dec 11, 2018
High RiskFDA
Baxter Healthcare Corporation
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in th...
Medical Devices·1,085 affected·Dec 11, 2018
High RiskFDA
Baxter Healthcare Corporation
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the...
Medical Devices·7,688 affected·Dec 11, 2018
High RiskFDA
Kimberly-clark Corporation
U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack
Medical Devices·68,852,076 affected·Dec 11, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
DrNatura Toxinout Kit Broad Spectrum Detoxification Program
Food·800 affected·Dec 10, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
DrNatura Flora Protect¿ Probiotics
Food·2,378 affected·Dec 10, 2018
RecallFDA
Cbi Laboratories, Inc.
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Drugs·5,363 affected·Dec 10, 2018
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Sri...
Oral Drugs·4,404 affected·Dec 10, 2018
RecallFDA
Cbi Laboratories, Inc.
Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Ski...
Drugs·2,055 affected·Dec 10, 2018
High RiskFDA
Gordon Laboratories
Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon L...
Drugs·1,155 affected·Dec 10, 2018
High RiskFDA
Signature Orthopedics Pty Limited
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Medical Devices·10 affected·Dec 10, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical i...
Surgical Devices·65 affected·Dec 10, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical i...
Surgical Devices·46 affected·Dec 10, 2018
High RiskFDA
Leica Biosystems Imaging, Inc.
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Medical Devices·3 affected·Dec 10, 2018
High RiskFDA
Luminex Corporation
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Diagnostic Devices·1 affected·Dec 10, 2018
High RiskFDA
Moonstruck Chocolate Company
The Salty Nutty Toffee Bar, brand ALMA, net weight 1.85 oz. UPC on individual bar: 8 58533 00602 8 UPC on master case 0 108585 33006...
Dairy·323 affected·Dec 7, 2018
High RiskFDA
Threshold Enterprises Ltd
Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0...
Produce·16 affected·Dec 7, 2018
CriticalFDA
Procesadora De Dulces Tipicos, S.a. De C.v.
Tamy Pop 18 pieces Net Wt. 1 lb. 15.7 oz. packaged in a clear plastic jar, 6 jars per case
Food·417 affected·Dec 7, 2018
CriticalFDA
Procesadora De Dulces Tipicos, S.a. De C.v.
FLECHAZO 36 pieces Net Wt. 1 lb. 12.5 oz. packaged in a clear plastic jar, 6 jars per case
Food·87 affected·Dec 7, 2018