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High RiskFDA
Givaudan Flavours Corp
Nat Maple Flavor WONF, 20.412 kg in each 6 gallon blue HDPE jerri-can, UPC: 20357342262
Food·934 affected·Nov 21, 2019
High RiskFDA
Endorphin Farms, Inc.
Tobago Keys brand Coral Ridge Seafood Dipping Sauce 12 FL.OZ. (355 ml) and Peruvian Gold Grilling Sauce 12 FL.OZ (355 ml)
Seafood·83 affected·Nov 21, 2019
High RiskFDA
Pacira Pharmaceuticals, Inc.
EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira...
Injectable Drugs·910 affected·Nov 21, 2019
High RiskFDA
Preferred Pharmaceuticals, Inc
Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawt...
Oral Drugs·0 affected·Nov 21, 2019
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained ...
Medical Devices·1,233 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version ...
Medical Devices·0 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for ...
Diabetes Devices·0 affected·Nov 21, 2019
High RiskFDA
Caire, Inc.
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the adminis...
Respiratory Devices·4 affected·Nov 21, 2019
High RiskFDA
Deroyal Industries Inc
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Medical Devices·2,789 affected·Nov 21, 2019
High RiskFDA
Stryker Gmbh
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product...
Medical Devices·0 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
Diabetes Devices·0 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-...
Medical Devices·0 affected·Nov 21, 2019
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by train...
Medical Devices·544 affected·Nov 21, 2019
High RiskFDA
Worldwide Seafood Products Llc
103200 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb cases and 103205 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb packed by Truong Phu...
Seafood·1,645 affected·Nov 20, 2019
CriticalFDA
Kerry, Inc
DaVinci Gourmet, Classic Caramel Flavored Sauce, 128 FL OZ (1 GAL), in plastic jugs
Food·100 affected·Nov 20, 2019
High RiskFDA
Lamb Weston Inc
Lamb Weston Grown In Idaho Crispy Hash Brown Dices, packaged in 28 ounce poly retail bags, 6 or 12 bags packaged in a master case. UPC: ...
Food·6,062 affected·Nov 20, 2019
RecallFDA
Idelle Labs
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 M...
Drugs·0 affected·Nov 20, 2019
High RiskFDA
American Health Packaging
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packag...
Oral Drugs·53,619 affected·Nov 20, 2019
CriticalFDA
Auromedics Pharma Llc
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Oral Drugs·0 affected·Nov 20, 2019
RecallFDA
Idelle Labs
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made i...
Drugs·0 affected·Nov 20, 2019
CriticalFDA
Auromedics Pharma Llc
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Oral Drugs·0 affected·Nov 20, 2019
RecallFDA
Idelle Labs
SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 3102...
Drugs·0 affected·Nov 20, 2019
RecallFDA
Idelle Labs
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made...
Drugs·0 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490425
Medical Devices·2,736 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490293
Medical Devices·1,050 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490530
Medical Devices·9,000 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490314
Medical Devices·5,616 affected·Nov 20, 2019
High RiskFDA
Philips North America, Llc
ProxiDiagnost N90
Diagnostic Devices·71 affected·Nov 20, 2019
High RiskFDA
Datascope Corporation
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET I...
Surgical Devices·523 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Safeline Y-Type Blood Set, Catalog Number V2500
Medical Devices·19,500 affected·Nov 20, 2019
High RiskFDA
Gh Imports, Inc
Onion Minced: 16-40 Mesh, Net Weight: 24/kg/52.91lbs, Manufacturing Date: May, 2019, Country of Origin: China, Manufactured for GH Import...
Produce·1,020 affected·Nov 19, 2019
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Drugs·22,336 affected·Nov 19, 2019
High RiskFDA
Auromedics Pharma Llc
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Oral Drugs·0 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·16 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at lea...
Respiratory Devices·5 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2...
Respiratory Devices·48 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea...
Respiratory Devices·8 affected·Nov 19, 2019
High RiskFDA
Angiodynamics, Inc.
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are i...
Medical Devices·160 affected·Nov 19, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the ca...
Diagnostic Devices·844 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least...
Respiratory Devices·105 affected·Nov 19, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADV...
Diagnostic Devices·1,306 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least ...
Respiratory Devices·29 affected·Nov 19, 2019
High RiskFDA
Angiodynamics, Inc.
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during ...
Medical Devices·4 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients wei...
Respiratory Devices·21 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·27 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·31 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing a...
Respiratory Devices·1 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing...
Respiratory Devices·15 affected·Nov 19, 2019