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High RiskFDA
Cardinal Health 200, Llc
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery...
Medical Devices·314,460 affected·Sep 22, 2020
High RiskFDA
Boston Scientific Corporation
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a...
Medical Devices·1 affected·Sep 22, 2020
High RiskFDA
Smith & Nephew, Inc.
5.5MM Arthrogarde Hip Access Cannula
Medical Devices·143 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for...
Medical Implants·4 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for...
Medical Implants·4 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical,...
Medical Implants·5 affected·Sep 21, 2020
CriticalFDA
Stryker Neurovascular
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 930...
Medical Devices·5,365 affected·Sep 21, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac a...
Cardiac Devices·64 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic...
Medical Implants·7 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic ...
Medical Implants·23 affected·Sep 21, 2020
High RiskFDA
Conformis, Inc.
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components ...
Medical Devices·2 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, ...
Medical Implants·18 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, tho...
Medical Implants·12 affected·Sep 21, 2020
CriticalFDA
Renaissance Food Group Llc
Trader Joe's Southwest Style Sweet Potato Saut¿ Bowl NET WT. 21.05oz (1 LB 5.5 OZ) 610g UPC 00661126 packaged in a clear plastic bowl wit...
Food·1,512 affected·Sep 20, 2020
High RiskFDA
Dianne's Fine Desserts
Devonshire Bake Shop brand Lemon Italian Cream Cake, 10 , Yellow Cake Filled With Italian Lemon Cream, 12 slices
Dairy·770 affected·Sep 19, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems de...
Diagnostic Devices·100 affected·Sep 18, 2020
High RiskFDA
Homestead Creamery, Inc.
All Natural Chocolate Pecan ice cream, 2.5 gallons, UPC:7525200120. Packaged in a plastic container
Dairy·3 affected·Sep 17, 2020
High RiskFDA
Seafarers Inc
Frozen Yellowfin Tuna Loins, Vacuum Packed, Imported and Distributed by Seafarers, Inc, 5-8 LBS, Product of Vietnam
Seafood·20 affected·Sep 17, 2020
CriticalFDA
Homestead Creamery, Inc.
Chocolate Ice Cream, 1 quart, UPC:87525200107. Packaged in paper quart container.
Dairy·203 affected·Sep 17, 2020
RecallFDA
Grato Holdings, Inc.
Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0...
Drugs·399 affected·Sep 17, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta...
Oral Drugs·19,296 affected·Sep 17, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharett...
Oral Drugs·9,816 affected·Sep 17, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Table...
Oral Drugs·20 affected·Sep 17, 2020
High RiskFDA
Getinge Group Logistics America, Llc
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it ...
Respiratory Devices·431 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2089610-001-S
Medical Devices·4,794 affected·Sep 17, 2020
High RiskFDA
Genicon, Inc.
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever...
Medical Devices·8,872 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the c...
Respiratory Devices·2 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Medical Devices·37 affected·Sep 17, 2020
High RiskFDA
Quidel Corporation
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with...
Diagnostic Devices·10,537 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support t...
Respiratory Devices·88 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2096513-001-S
Medical Devices·2 affected·Sep 17, 2020
CriticalCPSC
Online At Www.monoprice.com And Www.amazon.com To Consumers, It Installation Companies, Construction, And Other Businesses From December 2018 Through February 2020 For Between $20 And $130 Per Box, Depending On Length And Color.
Monoprice Recalls Ethernet Cables Due to Fire Hazard
Electronics·10,800 affected·Sep 16, 2020
CriticalCPSC
The Wgen500dfv Was Sold At Sam's Club Nationwide And Online At Samsclub.com. The Igen4500df Was Sold Online At Amazon.com, Homedepot.com, Lowes.com, Electricgeneratorsdirect.com, Powerequipmentdirect.com, Norwall.com, And Other Online Locations. The Generators Were Sold From January 2020 Through May 2020 For Between $450 And $1,050, Depending On The Model.
MWE Investments Recalls Westinghouse Portable Generators Due to Fire Hazard
Furniture·7,500 affected·Sep 16, 2020
RecallCPSC
Rh Galleries And Outlets Nationwide And Online At Www.rh.com From October 2018 Through June 2020 For Between $190 And $1,500.
RH Recalls Industrial Three-Panel Mirrors Due to Injury Hazard
Kitchenware·270 affected·Sep 16, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, ...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Perrigo Company Plc
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Ph...
Drugs·7,775,813 affected·Sep 16, 2020
RecallFDA
Arbor Pharmaceuticals Inc.
Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx ...
Oral Drugs·1,846 affected·Sep 16, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)0088445...
Medical Devices·3,385,442 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450...
Medical Devices·159,396 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit...
Medical Devices·371,528 affected·Sep 16, 2020
RecallUSDA
Willow Tree Poultry Farm, Inc.
Willow Tree Poultry Farm, Inc. Recalls Ready-To-Eat Chicken Salad Products due to Misbranding and an Undeclared Allergen
Pork·0 affected·Sep 16, 2020
High RiskFDA
Medline Industries Inc
Quick Release Gait Belt, 60
Medical Devices·13,500 affected·Sep 15, 2020
High RiskFDA
3m Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50...
Medical Devices·10,145,050 affected·Sep 15, 2020
High RiskFDA
Becton Dickinson & Company
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are int...
Surgical Devices·12,020 affected·Sep 14, 2020
RecallFDA
Invivo Corporation
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anato...
Diagnostic Devices·12,764 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits c...
Medical Devices·80 affected·Sep 14, 2020