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High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) AN...
Medical Devices·512,786 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; ...
Medical Devices·512,786 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 )...
Medical Devices·512,786 affected·Nov 8, 2024
High RiskFDA
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Diagnostic Devices·3 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC4...
Medical Devices·512,786 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB;...
Medical Devices·973,785 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalo...
Medical Devices·512,786 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Medical Devices·973,785 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) K...
Medical Devices·512,786 affected·Nov 8, 2024
High RiskFDA
O&m Halyard, Inc.
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Surgical Devices·211 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4F...
Medical Devices·973,785 affected·Nov 8, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Numbe...
Medical Devices·973,785 affected·Nov 8, 2024
RecallCPSC
Exclusively Online At Temu.com From June 2024 Through August 2024 For Between $25 And $30.
Baofali Crib Bumpers Recalled Due to Suffocation Hazard; Violation of Federal Ban on Crib Bumpers; Sold Exclusively on Temu.com by Unique Person Home Goods
Children's Products·390 affected·Nov 7, 2024
RecallCPSC
Beall's Outlet Stores, Burlington Merchandising, Dd's Discounts, Macy's Backstage, Marshalls, Nordstrom Rack, And Tj Maxx Stores Nationwide From January 2024 Through May 2024 For Between $6 And $9.
Dreamgro Recalls Lullaby Travel Soothers Due to Choking Hazard
Consumer Products·25,900 affected·Nov 7, 2024
CriticalCPSC
Online At Amazon.com, Https://us.govee.com, The Govee Home App And Tiktok Shop From September 2021 Through September 2024 For Between $30 And $150.
GoveeLife and Govee Smart Electric Space Heaters Recalled Due to Fire and Burn Hazards; Imported by Govee
Heating & Cooling·512,500 affected·Nov 7, 2024
RecallCPSC
Online At Www.guavafamily.com And Www.babylist.com From August 2020 Through October 2023 For Between $500 And $550.
Guava Family Recalls Roam Strollers Due to Fall and Injury Hazards
Children's Products·8,500 affected·Nov 7, 2024
CriticalCPSC
Online At Www.kytebaby.com From November 2022 Through March 2024 For About $75.
Kyte Baby Recalls Slumber Suits Due to Burn Hazard; Violation of Federal Flammability Regulations; Sold Exclusively on Kytebaby.com
Children's Products·20,500 affected·Nov 7, 2024
CriticalCPSC
Online At Www.quadlockcase.com And Www.amazon.com And Through Various Third-party Sellers Worldwide From April 2023 Through September 2024 For Between $60 And $80.
Quad Lock MAG Battery Pack Recalled Due to Fire Hazard; Imported by Quad Lock
Batteries & Power·13,700 affected·Nov 7, 2024
CriticalCPSC
Online At West Elm, One Kings Lane, Lumens, Lulu & Georgia, Lightology And Anthropologie From September 2021 Through July 2024 For Between $275 And $495.
Tala North America Recalls Battery Powered Portable Lamps Due to Fire Hazard
Furniture·5,300 affected·Nov 7, 2024
CriticalCPSC
Home Appliance Stores Nationwide From August 2020 Through September 2024 For Between $12,500 And $23,000.
Wolf Appliance Recalls Dual Fuel Ranges with Infrared Griddles Due to Burn and Fire Hazards
Appliances·44,000 affected·Nov 7, 2024
High RiskFDA
Cumberland Packing Corp.
Organic Hot Agave in the Raw, 10 oz.
Food·549 affected·Nov 7, 2024
High RiskFDA
Aurobindo Pharma Usa Inc
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, ...
Oral Drugs·3,336 affected·Nov 7, 2024
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, N...
Drugs·0 affected·Nov 7, 2024
High RiskFDA
Aurobindo Pharma Usa Inc
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only,...
Oral Drugs·102,576 affected·Nov 7, 2024
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, ...
Drugs·0 affected·Nov 7, 2024
High RiskFDA
Aurobindo Pharma Usa Inc
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only,...
Oral Drugs·0 affected·Nov 7, 2024
High RiskFDA
Diasorin Inc.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Medical Devices·21,905 affected·Nov 7, 2024
High RiskFDA
Armonia Natural Store Llc
OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature
Supplements·64 affected·Nov 6, 2024
High RiskFDA
Midlab Incorporated
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., S...
Drugs·0 affected·Nov 6, 2024
High RiskFDA
Midlab Incorporated
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOO...
Drugs·0 affected·Nov 6, 2024
High RiskFDA
Tailstorm Health Inc
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 1...
Injectable Drugs·27,560 affected·Nov 6, 2024
High RiskFDA
Midlab Incorporated
boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfiel...
Drugs·0 affected·Nov 6, 2024
High RiskFDA
Midlab Incorporated
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 1023...
Drugs·0 affected·Nov 6, 2024
High RiskFDA
Midlab Incorporated
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, ...
Drugs·0 affected·Nov 6, 2024
High RiskFDA
Trinity Gold Nutrition
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, ...
Oral Drugs·150 affected·Nov 6, 2024
High RiskFDA
Midlab Incorporated
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLA...
Drugs·0 affected·Nov 6, 2024
High RiskFDA
Abbott Vascular Inc
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Medical Devices·23,407 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Medical Devices·160 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Medical Devices·40 affected·Nov 6, 2024
High RiskFDA
Abbott Vascular Inc
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or d...
Medical Implants·3,673 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVF...
Medical Devices·0 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Medical Devices·26 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Medical Devices·36 affected·Nov 6, 2024
High RiskFDA
Abbott Vascular Inc
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilat...
Surgical Devices·1,418 affected·Nov 6, 2024
High RiskFDA
St. Jude Medical
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System mo...
Cardiac Devices·25 affected·Nov 6, 2024
High RiskFDA
Icu Medical, Inc.
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. ...
Medical Devices·6,000 affected·Nov 6, 2024
High RiskFDA
Abbott Vascular Inc
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Medical Devices·4,975 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Medical Devices·318 affected·Nov 6, 2024