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High RiskFDA
Pfizer Inc.
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, In...
Injectable Drugs·94,752 affected·Oct 3, 2018
High RiskFDA
Silver Star Brands
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC ...
Oral Drugs·247 affected·Oct 3, 2018
CriticalFDA
Silver Star Brands
Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
Oral Drugs·67 affected·Oct 3, 2018
CriticalFDA
Apollo Food International Inc.
Mini Roll, The product comes in a 2.469 ounce pink plastic package marked with a production date of 2018.03.20 stamped on the back. The p...
Food·12 affected·Oct 2, 2018
CriticalFDA
Cfs West Holdings Inc
Houlihan's Creamy Garlic Ranch Dressing potentially labeled as Horseradish Sauce, 1 gal containers Mfg. exclusively for: Houlihan's Resta...
Food·293 affected·Oct 2, 2018
High RiskFDA
Jubilant Cadista Pharmaceuticals, Inc.
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 24...
Oral Drugs·158,466 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long n...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·38 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·2 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long n...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·8 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and l...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and lo...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·19 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·3 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·5 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·26 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and l...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Pfizer Inc.
Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of min...
Medical Devices·293,880 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·8 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·5 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink Encore 29901 Programmer
Medical Devices·4,072 affected·Oct 2, 2018
High RiskFDA
Pfizer Inc.
Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary re...
Medical Devices·119,232 affected·Oct 2, 2018
High RiskFDA
Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5053
Cardiac Devices·2,108 affected·Oct 2, 2018
High RiskFDA
Nutranext Business Llc
Internal Cleansing Kit Peppermint
Food·2,387 affected·Oct 1, 2018
High RiskFDA
Nutranext Business Llc
Parasite Cleansing Kit Peppermint
Food·839 affected·Oct 1, 2018
High RiskFDA
Nutranext Business Llc
Parasite Cleansing Kit Ginger
Food·2,472 affected·Oct 1, 2018
High RiskFDA
Nutranext Business Llc
Toxin Absorber with Organic Peppermint Leaf - 14 packets and 30 packets
Food·1,986 affected·Oct 1, 2018
High RiskFDA
Pepsico Gatorade Plant
Gatorade Vanilla Protein Shake, 330-mL, Primary Package HDPE in a 12pk case
Food·12 affected·Oct 1, 2018
High RiskFDA
Nutranext Business Llc
Internal Cleansing Kit Ginger
Food·6,144 affected·Oct 1, 2018
High RiskFDA
Nutranext Business Llc
Colon Cleansing Kit Peppermint
Food·7,638 affected·Oct 1, 2018
High RiskFDA
Svs Llc
PremierPro Aluminum Adjustable Walker
Medical Devices·256 affected·Oct 1, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
C3 Wave App, v. 2.0.5
Medical Devices·24 affected·Oct 1, 2018
High RiskFDA
Comet Technologies Usa Inc
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Medical Devices·93 affected·Oct 1, 2018
High RiskFDA
Comet Technologies Usa Inc
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Medical Devices·77 affected·Oct 1, 2018
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Medical Devices·46 affected·Oct 1, 2018
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250i
Medical Devices·1 affected·Oct 1, 2018
CriticalFDA
Working Cow Homemade Inc.
Vanilla Bean Ice Cream, 3 gallons
Dairy·8,286 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
JY Spiderman Ice Cream, 3 gallons
Dairy·42 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
Coffee House Crunch Ice Cream, 3 gallons
Dairy·806 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
JY Gator Tracks Ice Cream, 3 gallons
Dairy·13 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
No Sugar Added Chocolate Ice Cream, 3 gallons
Dairy·856 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
French Vanilla Ice Cream, 3 gallons
Dairy·3,738 affected·Sep 28, 2018
CriticalFDA
Working Cow Homemade Inc.
JY Salted Caramel Ice Cream, 3 gallons
Dairy·134 affected·Sep 28, 2018