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High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Confidence -Computed tomography systems Model 10590100
Medical Devices·108 affected·Nov 19, 2021
High RiskFDA
Spice House
The Spice House Sichuan Chile BBQ Rub 2.7oz glass jar UPC 816328028240
Food·737 affected·Nov 18, 2021
High RiskFDA
Motts Llp
Motts No Sugar Added Apple Sauce - 3.9 oz.
Food·528 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock R...
Injectable Drugs·3,077 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd S...
Injectable Drugs·1,605 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd St...
Injectable Drugs·896 affected·Nov 17, 2021
High RiskFDA
Medshape, Inc.
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medical Devices·26 affected·Nov 17, 2021
High RiskFDA
Stanley Security Solutions Inc
Senior Living Arial Emergency and Nurse Call Systems
Medical Devices·11 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Medical Devices·680 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery....
Medical Devices·1,170 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK...
Medical Devices·920 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Medical Devices·120 affected·Nov 17, 2021
High RiskFDA
Abbott
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Medical Devices·10 affected·Nov 16, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Respiratory Devices·14 affected·Nov 16, 2021
High RiskFDA
Ohio Medical Corporation
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac ...
Medical Devices·649 affected·Nov 16, 2021
High RiskFDA
King's Hawaiian Bakery
Kings Hawaiian Hawaiian Sweet Hamburger Buns8 buns NET WT 12.8 oz. (362.9 g) UPC 0 73435-06050 Product Number 800020
Food·336 affected·Nov 15, 2021
High RiskFDA
Sterrx, Llc
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 129...
Injectable Drugs·880 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·1,044 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC...
Injectable Drugs·36,576 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1290...
Injectable Drugs·74,508 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1...
Injectable Drugs·10,660 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY...
Injectable Drugs·20,640 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903,...
Injectable Drugs·3,540 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903...
Injectable Drugs·127,260 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #7...
Injectable Drugs·15,660 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·40 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903,...
Injectable Drugs·24,300 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC...
Injectable Drugs·36,360 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1290...
Injectable Drugs·121,584 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Injectable Drugs·2,886 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, N...
Drugs·18,948 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7032...
Injectable Drugs·9,360 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY...
Injectable Drugs·5,000 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903,...
Injectable Drugs·5,832 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ...
Injectable Drugs·684 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, N...
Injectable Drugs·2,779 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·8,946 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ...
Injectable Drugs·26,928 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY ...
Injectable Drugs·23,136 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ...
Injectable Drugs·7,548 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, ...
Injectable Drugs·880 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903...
Injectable Drugs·1,428 affected·Nov 12, 2021
High RiskFDA
Invacare Corporation
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, ...
Medical Devices·303 affected·Nov 12, 2021
High RiskFDA
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency ...
Medical Devices·10 affected·Nov 12, 2021
High RiskFDA
Covidien Llc
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery cha...
Medical Devices·2 affected·Nov 12, 2021
High RiskFDA
Cook Inc.
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduc...
Diagnostic Devices·47 affected·Nov 12, 2021
High RiskFDA
Kraft Heinz Foods Company
Kool-Aid cherry drink mix powder 19 oz. UPC 043000953532 19 oz. UPC 043000034163 63 oz. UPC 043000082201
Beverages·289,221 affected·Nov 11, 2021
High RiskFDA
Kraft Heinz Foods Company
Country Time Lemonade drink mix powder 19 oz. UPC 043000951170 29 oz. UPC 043000951194 63 oz. UPC 043000082195 82.5 oz. UPC 04300092...
Beverages·289,221 affected·Nov 11, 2021