Skip to main content
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Ge Healthcare, Llc
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT ...
Respiratory Devices·4,207 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S...
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)1805424251...
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
Medical Devices·0 affected·Sep 27, 2018
High RiskFDA
Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
Medical Devices·0 affected·Sep 27, 2018
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
Medium RiskCPSC
Boy Scouts Of America Retail Stores And Authorized Distributors Nationwide And Online At Www.scoutshop.org From February 2018 Through August 2018 For About $6.
Boy Scouts of America Recalls Neckerchief Slides Due to Violation of Federal Lead Content Ban
Consumer Products·110,000 affected·Sep 26, 2018
CriticalCPSC
Cfmoto Dealers Nationwide From November 2015 Through July 2018 For Between $4,200 And $6,000.
CFMOTO Recalls All-Terrain Vehicles Due to Fire Hazard
Vehicles / Atvs·5,300 affected·Sep 26, 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
CriticalFDA
Medtronic Navigation, Inc.
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedu...
Medical Devices·5,487 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
CriticalFDA
Oscor, Inc.
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packa...
Cardiac Devices·36,688 affected·Sep 26, 2018
RecallCPSC
Apotheco Pharmacy, Memorial Medical Center, Oschner Baptist Medical Center, Oschner Wellness, The Herb Bar, Current Medical Technologies, Be Well Pharmacy, Women's Physical Therapy, Other Pharmacies Nationwide, And Online At Amazon.com And Desertharvest.com From January 2016 Through July 2018 For About $27 For The 4 Ounce Bottle And About $50 For The 8 Ounce Bottle.
Desert Harvest Recalls Reléveum Skin Repair Cream Due to Failure to Meet Child Resistant Closure Requirements
Children's Products·1,450 affected·Sep 25, 2018
CriticalCPSC
Distributed As A Free Promotional Item From August 2017 Through July 2018 In Mailings Nationwide And In-person During Employer Wellness Events In Oregon, North Carolina And Arizona.
Provata Health Recalls Promotional Activity Trackers Due to Burn Hazard
Consumer Products·30,000 affected·Sep 25, 2018
CriticalCPSC
Costco, Ace Hardware Stores, Other Stores Nationwide, And Online From March 2018 Through July 2018 For Between $300 And $400.
Traeger Grills Recalls Wood Pellet Grills Due to Fire Hazard
Furniture·16,100 affected·Sep 25, 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
RecallFDA
Right Value Drug Stores, Inc.
Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy...
Oral Drugs·180 affected·Sep 25, 2018
RecallFDA
Right Value Drug Stores, Inc.
Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevin...
Oral Drugs·8,240 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
RecallFDA
Right Value Drug Stores, Inc.
Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy....
Oral Drugs·660 affected·Sep 25, 2018
RecallFDA
Right Value Drug Stores, Inc.
Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevin...
Oral Drugs·6,580 affected·Sep 25, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 360...
Injectable Drugs·523,896 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