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High RiskFDA
Ventura Foods, Llc
Gordon Choice Thousand Island Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ;...
Food·295 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
Rio Pacific Foods Deluxe BBQ Sauce; 3.78 litre; Produced in the USA for Funnybones Foodservice Ltd, Hertfordshire AL7 1HW; Lot #120117
Produce·3 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
Single-serve plastic packet Italian Dressing; Case packing: Sysco Classic Cls Italian 500 12Gm ; 47014SYS; B13017; single-serve plast...
Food·78 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
Gordon Choice Honey Mustard Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ; C...
Food·52 affected·Dec 7, 2017
High RiskFDA
Johnson & Johnson
Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distrib...
Drugs·0 affected·Dec 7, 2017
High RiskFDA
Sca Pharmaceuticals
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 K...
Drugs·1,248 affected·Dec 7, 2017
High RiskFDA
Johnson & Johnson
Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by ...
Drugs·67,260 affected·Dec 7, 2017
High RiskFDA
Johnson & Johnson
Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866
Drugs·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
VISIONIST CRT-P Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ESSENTIO DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ALTRUA 2 EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Helena Laboratories, Corp.
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Medical Devices·21 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ESSENTIO SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/...
Medical Devices·6 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ALTRUA 2 SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Intel-ge Care Innovations Llc
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool...
Medical Devices·1,302 affected·Dec 6, 2017
High RiskFDA
Solco Healtcare Us Llc
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbur...
Oral Drugs·0 affected·Dec 4, 2017
High RiskFDA
Allergan
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufac...
Oral Drugs·12,699 affected·Dec 4, 2017
High RiskFDA
Smiths Medical Asd Inc.
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK...
Medical Devices·1,077 affected·Dec 4, 2017
High RiskFDA
Konica Minolta Medical Imaging Usa, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Medical Devices·17 affected·Dec 4, 2017
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro...
Diabetes Devices·14,340 affected·Dec 4, 2017
High RiskFDA
Cellavision Ab
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Produc...
Medical Devices·224 affected·Dec 4, 2017
High RiskFDA
Accord Media, Llc
Ultra Renew Plus
Medical Devices·1,040 affected·Dec 4, 2017
High RiskFDA
Konica Minolta Medical Imaging Usa, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 0456014...
Medical Devices·30 affected·Dec 4, 2017
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The ...
Diagnostic Devices·9 affected·Dec 4, 2017
High RiskFDA
Elekta, Inc.
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Inf...
Medical Devices·2,998 affected·Dec 1, 2017
High RiskFDA
Mako Surgical Corporation
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Medical Devices·126 affected·Dec 1, 2017
High RiskFDA
Stryker Sustainability Solutions
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventin...
Medical Devices·280 affected·Dec 1, 2017
High RiskFDA
Ohmeda Medical
Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purcha...
Medical Devices·1,179 affected·Dec 1, 2017
High RiskFDA
Raley's
Raley's All Butter Meyer Lemon Cookie; Case of Raw Dough (168 cookies) 28.87 lbs - UPC 10659728; 1 cookie (85 g); 6 count package UPC ...
Dairy·57 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and No...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 ...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 an...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 ...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Donkey Salsa
SALSA HOT Net Wt. 15 oz (426 G)
Food·216 affected·Nov 29, 2017
High RiskFDA
Donkey Salsa
SALSA NOT HOT Net Wt. 15 oz (426G)
Food·216 affected·Nov 29, 2017
High RiskFDA
Prinston Pharmaceutical Inc
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhe...
Oral Drugs·21,987 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical Implants·13,227 affected·Nov 29, 2017