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High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032...
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)1...
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Albertsons Inc
Signature Reserve Bourbon Maple Blondie Ice Cream 14 FL OZ UPC 2113009912
Dairy·2,144 affected·Sep 26, 2018
High RiskFDA
Bounty Foods, Inc
Deep Pit Seasoning, net wt. 6 oz., packaged in a clear, wide mouth jar, black and white label with black lid. The product label is rea...
Produce·60 affected·Sep 26, 2018
High RiskFDA
Glaxosmithkline Nebraska
Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14),...
Oral Drugs·5,548,673 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: Th...
Diagnostic Devices·490 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The...
Diagnostic Devices·217 affected·Sep 26, 2018
High RiskFDA
Accuray Incorporated
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic ra...
Medical Devices·93 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component...
Diagnostic Devices·264 affected·Sep 26, 2018
High RiskFDA
Becton Dickinson & Company
PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Id...
Medical Devices·566,737 affected·Sep 26, 2018
High RiskFDA
Whole Foods Market
365 Everyday Value Brand White Corn Chips, Salted NET WT 20 oz. (1 LB 4 OZ) 567 g packaged in a plastic bag
Snacks & Candy·2,975 affected·Sep 25, 2018
High RiskFDA
Rxq Compounding Llc
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC ...
Drugs·395 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 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 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 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 30mm, Catalog Number: ZIB6-80-5.0-30 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 60mm, Catalog Number: ZIB6-80-12.0-60 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 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,384 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Dt Medtech, Llc
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Medical Implants·1 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 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 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 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: ZIB6-80-5.0-20 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