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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
CriticalFDA
Quantum Inc
Quantum Health branded Elderberry liquid herbal extract dietary supplement is packaged in 2oz glass bottle, 12 bottles/case. Product is ...
Produce·5 affected·Nov 6, 2020
High RiskFDA
The Kroger Co
HomeChef meal kit: Buffalo Pretzel Chicken Breast with Roasted Cauliflower and Broccoli. 29 ounce.
Meat & Poultry·1,080 affected·Nov 6, 2020
High RiskFDA
The Kroger Co
HomeChef Meal kit:One-Sheet Pretzel-Crusted Chicken with roasted broccoli and honey mustard..31.0 OZ (1 LB 15 OZ) 879g
Meat & Poultry·2,814 affected·Nov 6, 2020
High RiskFDA
Jubilant Cadista Pharmaceuticals, Inc.
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbu...
Oral Drugs·4,416 affected·Nov 6, 2020
High RiskFDA
John Nagle Co.
John Nagle Steelhead Fillets; 1/3 lb; Iceland; N44515; Habrun ehf; Packaging date: 29 10 2020
Food·5 affected·Nov 5, 2020
RecallFDA
Teligent Pharma, Inc.
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
Topical Drugs·20,160 affected·Nov 5, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medical Implants·3 affected·Nov 5, 2020
High RiskFDA
Medline Industries Inc
RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Produ...
Medical Devices·15,780 affected·Nov 5, 2020
High RiskFDA
K2m, Inc
Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrumen...
Medical Devices·197 affected·Nov 4, 2020
RecallFDA
Teligent Pharma, Inc.
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-01...
Drugs·4,008 affected·Nov 3, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mf...
Injectable Drugs·2,100,646 affected·Nov 3, 2020
High RiskFDA
Boston Scientific Corporation
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter...
Surgical Devices·90 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product C...
Medical Devices·100,000 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
Medical Devices·50 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ...
Surgical Devices·11,000 affected·Nov 3, 2020
High RiskFDA
K2m, Inc
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides ...
Medical Devices·4 affected·Nov 3, 2020
High RiskFDA
Kowa Optimed Inc
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicat...
Medical Devices·0 affected·Nov 3, 2020
High RiskFDA
Neosteo
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Medical Devices·25 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
Medical Devices·6,470 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
Medical Devices·93,700 affected·Nov 3, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironic...
Respiratory Devices·3,213 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·534 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·9,856 affected·Nov 2, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screen...
Medical Devices·362 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·934 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·10,291 affected·Nov 2, 2020