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High RiskFDA
Taylor Farms Northwest, Llc
Item #140952, Tuna Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in fo...
Dairy·577 affected·Feb 26, 2021
High RiskFDA
Taylor Farms Northwest, Llc
Item #140946, Chicken Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in...
Dairy·750 affected·Feb 26, 2021
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ ...
Oral Drugs·16,449 affected·Feb 26, 2021
High RiskFDA
Alvogen, Inc
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Br...
Drugs·9,696 affected·Feb 26, 2021
High RiskFDA
Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1...
Medical Implants·23,123 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·0 affected·Feb 26, 2021
High RiskFDA
Accuray Incorporated
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for...
Medical Devices·243 affected·Feb 26, 2021
High RiskFDA
Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 110...
Medical Implants·23,123 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW G...
Diabetes Devices·497,747 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN...
Diabetes Devices·302,667 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ G...
Diabetes Devices·15,162 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTI...
Diabetes Devices·15,393 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN:...
Diabetes Devices·1,224,032 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·71,473 affected·Feb 26, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedur...
Diagnostic Devices·29 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN...
Diabetes Devices·111,678 affected·Feb 26, 2021
High RiskFDA
Covidien Llc
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring ...
Medical Devices·62,551 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTI...
Diabetes Devices·13,014 affected·Feb 26, 2021
High RiskFDA
Covidien Llc
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring...
Medical Devices·62,551 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Us...
Diabetes Devices·1,174 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: ...
Diabetes Devices·12,624 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: inte...
Diabetes Devices·1,863 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)108...
Cardiac Devices·0 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended ...
Diabetes Devices·5,571 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: ...
Diabetes Devices·54,211 affected·Feb 26, 2021
High RiskFDA
Cardinal Health 200, Llc
In-View Clear Leggings Sterile
Medical Devices·28,417 affected·Feb 25, 2021
High RiskFDA
Fenwal Inc
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Medical Devices·2,466 affected·Feb 25, 2021
High RiskFDA
Dutch Ophthalmic Usa, Inc.
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, pr...
Medical Devices·12 affected·Feb 25, 2021
High RiskFDA
Fenwal Inc
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Medical Devices·4,488 affected·Feb 25, 2021
High RiskFDA
Access Vascular, Inc.
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Surgical Devices·79 affected·Feb 24, 2021
High RiskFDA
Arthrex, Inc.
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Medical Devices·9 affected·Feb 24, 2021
High RiskFDA
Trinity Sterile, Inc.
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dres...
Surgical Devices·2,970 affected·Feb 23, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction o...
Surgical Devices·337 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·18 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replac...
Medical Implants·102 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:...
Surgical Devices·19 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, ti...
Medical Devices·355 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:D...
Surgical Devices·13 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace th...
Medical Devices·102 affected·Feb 22, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access...
Medical Implants·267 affected·Feb 22, 2021
High RiskFDA
Sirtex Medical Limited
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Medical Devices·3,310 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·15 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CE...
Surgical Devices·100 affected·Feb 22, 2021
High RiskFDA
Coolhaus
Coolhaus Awesome Dessert - Dairy Free Mocha Marcona Almond Fudge, Creamy Coffee Fudge Swirl & Marcona Almond Frozen Dessert. 16 fl.oz, ...
Dairy·432 affected·Feb 19, 2021
High RiskFDA
Green City Distribution
Al-Riyan Tuna Meat in Vegetable oil 7 oz. can 48 cans per case
Meat & Poultry·1,320 affected·Feb 19, 2021
High RiskFDA
Urban Remedy
Urban Remedy Organic Cacao Mocha Cold Brew Coffee; 16 FL. OZ (473 mL) UPC" 8 13377 02222 9 Ingredients: Cashew Milk (filtered water, c...
Dairy·208 affected·Feb 19, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene...
Topical Drugs·934,140 affected·Feb 19, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polyprop...
Topical Drugs·551,670 affected·Feb 19, 2021