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High RiskFDA
Becton Dickinson & Company
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, b...
Medical Devices·72 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·60 affected·Sep 14, 2020
High RiskFDA
Philips North America, Llc
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used...
Cardiac Devices·8,942 affected·Sep 14, 2020
High RiskFDA
Percussionaire Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Respiratory Devices·212 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·32 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Cardiac Devices·16 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist o...
Medical Devices·20 affected·Sep 14, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Medical Devices·9,907 affected·Sep 12, 2020
CriticalCPSC
Amazon.com From June 2018 Through June 2020 For Between $2 And $59.
Medique Recalls 31 Different Over-the-Counter Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively on Amazon.com (Recall Alert)
Children's Products·143,300 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Compan...
Topical Drugs·5,040 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywoo...
Topical Drugs·33,480 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company...
Topical Drugs·15,000 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For:...
Topical Drugs·8,600 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Kil...
Topical Drugs·5,320 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical e...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Skytron, Div. The Kmw Group, Inc
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Mo...
Medical Devices·11 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energ...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-...
Medical Devices·143 affected·Sep 11, 2020
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or ex...
Medical Devices·1 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive h...
Medical Devices·1,120 affected·Sep 11, 2020
RecallUSDA
Cher-make Sausage Company
Cher-Make Sausage Company Recalls Fully Cooked Meat Sausage Products Due to Misbranding and an Undeclared Allergen
Pork·0 affected·Sep 11, 2020
RecallCPSC
Online At Www.organicaromas.com From November 2017 Through January 2020 For Between $12 And $84.
Organic Aromas Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning (Recall Alert)
Children's Products·300 affected·Sep 10, 2020
RecallCPSC
Residential Elevators' Dealers And Home Builders Nationwide From January 2014 Through April 2017 For Between $18,000 And $50,000.
Residential Elevators Recalls Elevators Due to Impact Hazard (Recall Alert)
Consumer Products·6,300 affected·Sep 10, 2020
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Diabetes Devices·5,206 affected·Sep 10, 2020
RecallCPSC
Authorized Cannondale Dealers Nationwide From April 2019 Through June 2020 For Between $950 To $2,750 For The Bicycles Sold With The Front Racks, And $100 For The Racks Sold Separately. The Front Racks Were Included As Original Equipment On Some Bicycles; On Other Bicycles, The Front Racks Were Sold Separately As Ad-on Equipment.
Cycling Sports Group Recalls Front Racks for Cannondale Treadwell Bicycles Due to Fall Hazard
Bicycles & Wheeled Sports·1,975 affected·Sep 9, 2020
CriticalCPSC
Exclusively Online At Wayfair.com From August, 2017 Through November 2019 For About $240.
Royal Gourmet Recalls Deluxe Gas Grills Due to Fire Hazard; Sold Exclusively at Wayfair.com
Outdoor & Garden·1,100 affected·Sep 9, 2020
RecallCPSC
Online At Spinlife.com, Scootaround.com, Accessnsm.com And Topmobility.com And Other Online Retailers From November 2017 Through September 2019 For About $4,500.
WHILL Recalls WHILL Personal Electric Vehicles Due to Crash and Injury Hazards
Vehicles / Atvs·1,160 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Salted, 3-2.9 oz (82 g) bags, Net Wt. 8.7 o...
Snacks & Candy·1,890 affected·Sep 9, 2020
High RiskFDA
Shatto Milk Co
Shatto Milk Company, Brownie, Chocolate Brownie and Vanilla Ice Cream Sammich, Net Wt. 5 oz, Shatto Milk Company, Osborn, MO
Dairy·308 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Light microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Light Butter, 3-2.9 oz (82 g) bags, N...
Dairy·972 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Lightly salted microwave popcorn packaged in the following ways: 1) Cadia Organic Lightly Salted Popcorn, Net Wt. 9.9 oz (281 g) 3-3.3...
Dairy·320 affected·Sep 9, 2020
High RiskFDA
Shatto Milk Co
Shatto Milk Company, Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, Net Wt. 4.5 oz, Shatto Milk Company, Osborn, MO
Dairy·333 affected·Sep 9, 2020
High RiskFDA
Lidl Us Trading
Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes per case and 3 popcorn bags per box .
Dairy·3,782 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Cadia Organic Unsalted Microwave Popcorn, Net Wt. 8.4 oz (238 g) 3-2.8 oz (79 g) bags, KeHDistributors LLC, Naperville, IL, UPC 15369-01289
Snacks & Candy·34 affected·Sep 9, 2020
RecallFDA
P & L Developments, Llc
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp H...
Drugs·4,752 affected·Sep 9, 2020
CriticalFDA
Medek Llc
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. P...
Topical Drugs·256 affected·Sep 9, 2020
RecallFDA
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 N...
Oral Drugs·13,480 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological application...
Medical Devices·6 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Medical Devices·0 affected·Sep 9, 2020