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High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intend...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Medical Devices·1,724 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intende...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generi...
Medical Devices·1,724 affected·Sep 25, 2018
High RiskFDA
Pro-dex Inc
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches -...
Surgical Devices·68 affected·Sep 25, 2018
High RiskFDA
Dt Medtech, Llc
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Medical Implants·54 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intend...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Medical Devices·1,724 affected·Sep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Medical Devices·1,724 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intend...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Harris Teeter
Harris Teeter Low Fat FROZEN YOGURT cookies & cream 1.5 QUART (1.42l) CONTAINS: MILK, WHEAT, SOY PROUDLY DISTRIBUTED BY: HARRIS TEETER, L...
Dairy·7,218 affected·Sep 24, 2018
High RiskFDA
Becton Dickinson & Co.
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with ap...
Diagnostic Devices·49 affected·Sep 24, 2018
High RiskFDA
Becton Dickinson & Co.
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX Sy...
Diagnostic Devices·23 affected·Sep 24, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance...
Diabetes Devices·14,398 affected·Sep 24, 2018
RecallCPSC
Woodcraft Stores And Woodcraft Dealers Nationwide From April 2015 Through January 2017 For About $260.
Woodcraft Recalls Clip-On Adapters for Motorcycle Handlebars Due to Crash Hazard
Vehicles / Atvs·400 affected·Sep 21, 2018
CriticalFDA
Lloyd's Ice Cream Inc
Lic's REESE'S OREO, ONE QUART (946 mL), packed in Plastic quart container
Food·571 affected·Sep 21, 2018
RecallFDA
Victoria Gourmet, Inc.
Victoria Taylor's Seasonings - Blackening Rub, 6.4 oz., UPC: 666227015274, packaged in a glass jar with a lid
Food·21 affected·Sep 21, 2018
RecallFDA
Victoria Gourmet, Inc.
Victoria Taylor's Seasonings - New Orleans - 5.0 oz. UPC: 666227015090, packaged in a glass jar with lid
Food·17 affected·Sep 21, 2018
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (N...
Topical Drugs·35,020 affected·Sep 21, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC...
Oral Drugs·313 affected·Sep 21, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixtu...
Medical Devices·1,512 affected·Sep 21, 2018
High RiskFDA
Zimmer Biomet, Inc.
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medica...
Medical Implants·72 affected·Sep 21, 2018
High RiskFDA
Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Prod...
Surgical Devices·3,640 affected·Sep 21, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous a...
Medical Devices·141,120 affected·Sep 21, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous a...
Medical Devices·234,720 affected·Sep 21, 2018
High RiskFDA
The Metrix Company
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in a...
Medical Devices·332,640 affected·Sep 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instrumen...
Surgical Devices·12,639 affected·Sep 21, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Medical Devices·110 affected·Sep 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used...
Surgical Devices·12,639 affected·Sep 21, 2018
High RiskFDA
The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixtu...
Medical Devices·1,596 affected·Sep 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments u...
Surgical Devices·12,639 affected·Sep 21, 2018