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RecallFDA
Invatech Pharma Solutions, Llc
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 1...
Oral Drugs·0 affected·Nov 11, 2020
High RiskFDA
Integra Lifesciences Corp.
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures....
Surgical Devices·552 affected·Nov 11, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25...
Respiratory Devices·5,079 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Onl...
Respiratory Devices·6,000 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Respiratory Devices·16,000 affected·Nov 11, 2020
High RiskFDA
Intersurgical Inc
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Br...
Medical Devices·200 affected·Nov 11, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Medical Devices·3 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx...
Respiratory Devices·600 affected·Nov 11, 2020
High RiskFDA
Welch Allyn, Inc/mortara
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting elec...
Medical Devices·1,009 affected·Nov 11, 2020
RecallUSDA
Stuffed Foods Llc
Stuffed Foods LLC Recalls Frozen Snack Products Due to Misbranding and an Undeclared Allergen
Poultry·0 affected·Nov 11, 2020
RecallCPSC
Xtreme Swim Stores, Metro Swim Shops, Swim Suit West Stores Nationwide And Online From Arenasport.com And Amazon.com From February 2018 Through May 2020 For Between $35 And $45.
Arena North America Recalls Swim Snorkels Due to Choking Hazard
Consumer Products·3,350 affected·Nov 10, 2020
RecallCPSC
Bolek's Craft Supplys And Hobby Lobby Stores Nationwide And Online At Bolek's Craft Supplys, Notions Marketing, Petersen-arne, Hobby Lobby And Other Websites From January 2009 Through January 2020 For Between $3 And $13.
Bolek's Craft Supplys Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
Children's Products·5,600 affected·Nov 10, 2020
CriticalCPSC
Big Lots Stores Nationwide And Online From January 2020 Through June 2020 For About $480.
Fire Pit Tables Sold Exclusively at Big Lots Recalled Due to Fire Hazard; Manufactured by Sunjoy
Furniture·10,900 affected·Nov 10, 2020
CriticalCPSC
Kohl's Stores Nationwide And Online At Www.kohls.com From December 2019 Through October 2020 For About $20.
Kohl's Recalls Three-Wick SONOMA Goods For Life Branded Candles Due to Fire and Burn Hazards
Lighting·512,000 affected·Nov 10, 2020
RecallCPSC
Salsa Authorized Bicycle Dealerships Nationwide From September 2019 Through September 2020 For Between $2,700 And $5,800.
Quality Bicycle Products Recalls Salsa Cycles Cutthroat Bicycles Due To Injury Hazard
Bicycles & Wheeled Sports·600 affected·Nov 10, 2020
CriticalCPSC
Electronics And Home Goods Stores Nationwide And Online At Amazon.com And Ring.com From June 2020 Through October 2020 For Approximately $100.
Ring Recalls Video Doorbells (2nd Generation) Due to Fire Hazard
Consumer Products·350,000 affected·Nov 10, 2020
High RiskFDA
Eywa Pharma Inc
Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India -...
Oral Drugs·5,451 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The...
Surgical Devices·90 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angi...
Cardiac Devices·80 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/a...
Surgical Devices·42 affected·Nov 10, 2020
High RiskFDA
Tissuetech, Inc.
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Medical Devices·10 affected·Nov 10, 2020
High RiskFDA
Cryolife, Inc.
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the in...
Cardiac Devices·3 affected·Nov 10, 2020
High RiskFDA
Baxter Healthcare Corporation
MiniCap Extended Life PD Transfer Set
Medical Devices·72,771 affected·Nov 10, 2020
High RiskFDA
Tissuetech, Inc.
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Medical Devices·63 affected·Nov 10, 2020
High RiskFDA
Tissuetech, Inc.
PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
Medical Devices·75 affected·Nov 10, 2020
High RiskFDA
Mayer Brothers Apple Products, Inc.
1. Giant brand " Premium Apple Cider*** 64 fl. oz. (Half Gal) 1.89L***Distributed by Foodhold USA LLC, Landover, MD 20785" 2. "Nature'...
Food·27,189 affected·Nov 9, 2020
High RiskFDA
Roi Cps Llc
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regar...
Cardiac Devices·17,700 affected·Nov 9, 2020
High RiskFDA
Exactech, Inc.
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Medical Devices·14 affected·Nov 9, 2020
High RiskFDA
Shimadzu Medical Systems
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The devic...
Medical Devices·115 affected·Nov 9, 2020
High RiskFDA
Icu Medical, Inc.
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac out...
Cardiac Devices·220 affected·Nov 9, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·51 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·1,726 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·27 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·5,765 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·577 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·592 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·527 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·548 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·3,665 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·19,646 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·180 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·8,272 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·1,006 affected·Nov 7, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·819 affected·Nov 7, 2020
High RiskFDA
Bausch & Lomb Surgical, Inc.
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for place...
Medical Devices·31 affected·Nov 7, 2020
High RiskFDA
Rosebud's Ranch And Garden, Llc
Rosebud's brand Elderberry Syrup Kit in a 3 oz. clear stand-up pouch (GS1 Code 852782007834).
Produce·41 affected·Nov 6, 2020
CriticalFDA
Tanimura & Antle
Tanimura & Antle brand Romaine lettuce. 1 head 12,15,018 and 24 case Product of USA UPC: 2-27918 20314-9 Tanimura & Antle, Salin...
Produce·3,396 affected·Nov 6, 2020
High RiskFDA
Singh Trading Inc. Dba Roshni Foods
Green Raisins 200 grams (7 oz.) Packaged in plastic bags. Bar Code:992203621
Food·20 affected·Nov 6, 2020