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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
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
High RiskFDA
Lamb Weston Inc
Formed Hash Brown Patties, packaged in cardboard trays covered with plastic film, frozen products. The following brands are subject ...
Frozen Food·2,075 affected·Sep 20, 2018
High RiskFDA
Artisan Baking Company, Llc.
Village Baker SPECIALTY ARTISAN BREADS CINNAMON CHIP SOURDOUGH. The product is whole sliced loaves packed in clear plastic bags that are...
Bakery & Grains·6 affected·Sep 20, 2018
High RiskFDA
Tarry Medical Products, Inc.
Product comes in a plastic bag which is labeled as follows: DandleLION MEDICAL DandleLION KISSES ORAL USE ONLY SINGLE PATIENT USE SINGLE ...
Food·46 affected·Sep 20, 2018
High RiskFDA
Lamb Weston Inc
Murry's Hash Brown Potato Patties, packaged in cardboard trays covered with plastic film, frozen products. -Tray UPC 0 73744 04001 4, ...
Frozen Food·2,638 affected·Sep 20, 2018
High RiskFDA
Pfizer Inc.
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL...
Injectable Drugs·71,075 affected·Sep 20, 2018
High RiskFDA
Pfizer Inc.
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- N...
Oral Drugs·7,777 affected·Sep 20, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC...
Oral Drugs·1,373 affected·Sep 20, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Guava Pastry. The product is packed in a cardboard box. The firm marks the Guava Pastry option printed on the box. Labeling for the ca...
Bakery & Grains·975 affected·Sep 19, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Coconut & Cheese Pastry. The product is packed in a cardboard box. The firm marks the Coconut& Cheese Pastry option printed on the box. ...
Dairy·28 affected·Sep 19, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Cheese Pastry. The product is packed in a cardboard box. The firm marks the Cheese Pastry option printed on the box. Labeling on the c...
Dairy·706 affected·Sep 19, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Guava & Cheese Pastry. The product is packed in a cardboard box. The firm marks the Guava & Cheese Pastry option printed on the box. L...
Dairy·975 affected·Sep 19, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Apple Pastry. The product is packed in a cardboard box. The firm marks the Apple Pastry option printed on the box. Labeling on the car...
Bakery & Grains·32 affected·Sep 19, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Pineapple Pastry
Bakery & Grains·10 affected·Sep 19, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Coconut Pastry. The product is packed in a cardboard box. The firm marks the Coconut Pastry option printed on the box. Labeling on the...
Bakery & Grains·344 affected·Sep 19, 2018
High RiskFDA
Baker's Service Of South Florida, Inc.
Coconut and Pineapple Pastry. The product is packed in a cardboard box. The firm marks the Coconut and Pineapple Pastry option printed o...
Bakery & Grains·58 affected·Sep 19, 2018
High RiskFDA
Pfizer Inc.
Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc,...
Injectable Drugs·12,416 affected·Sep 19, 2018
High RiskFDA
Upsher Smith Laboratories, Inc.
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 083...
Oral Drugs·29,080 affected·Sep 19, 2018
High RiskFDA
Upsher Smith Laboratories, Inc.
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 083...
Oral Drugs·44,764 affected·Sep 19, 2018
High RiskFDA
Encore Medical, Lp
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Medical Devices·21 affected·Sep 19, 2018
High RiskFDA
Ozark Country Kitchen
Sorghum, Mfg. by Ozark Country Sorghum, Dunnegan, MO 65640, Net Wt. 2 lb. 14 OZ. packaged in glass jars
Food·0 affected·Sep 18, 2018
High RiskFDA
Oregon Heritage Developments Inc Dba Oregon Heritage Farms
Oregon Heritage Farms Family Blend Apple Cider, 100% Juice, 1 gallon plastic container, UPC: 8 53581 00202 0. The label is read in par...
Beverages·1,632 affected·Sep 18, 2018
High RiskFDA
Beckman Coulter Inc.
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage...
Diagnostic Devices·0 affected·Sep 18, 2018
High RiskFDA
Baxter Healthcare Corporation
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Medical Devices·354 affected·Sep 18, 2018