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High RiskFDA
Landauer
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Medical Devices·584 affected·Nov 15, 2023
High RiskFDA
Soclean, Inc
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Medical Devices·2,339,352 affected·Nov 15, 2023
High RiskFDA
Canon Medical System, Usa, Inc.
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary gra...
Medical Devices·2 affected·Nov 15, 2023
High RiskFDA
Baxter Healthcare Corporation
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Medical Devices·339,936 affected·Nov 15, 2023
High RiskFDA
Canon Medical System, Usa, Inc.
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The syst...
Medical Devices·1 affected·Nov 15, 2023
High RiskFDA
Baxter Healthcare Corporation
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 6...
Injectable Drugs·6,022,675 affected·Nov 14, 2023
High RiskFDA
Bard Peripheral Vascular Inc
BD Recanalization System, REF: BDRECANSYSTEM
Medical Devices·403 affected·Nov 14, 2023
High RiskFDA
Kinder Farms Llc
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distribu...
Oral Drugs·376,370 affected·Nov 13, 2023
High RiskFDA
Kinder Farms Llc
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distribute...
Oral Drugs·591,684 affected·Nov 13, 2023
High RiskFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Medical Devices·98,311 affected·Nov 13, 2023
High RiskFDA
Blue Belt Technologies, Inc
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Medical Devices·1,859 affected·Nov 13, 2023
High RiskFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Medical Devices·78,532 affected·Nov 13, 2023
High RiskFDA
Maquet Medical Systems Usa
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Medical Devices·1,213 affected·Nov 13, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bott...
Oral Drugs·1,941 affected·Nov 10, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bott...
Oral Drugs·5,626 affected·Nov 10, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufact...
Oral Drugs·2,502 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>...
Medical Devices·1,639 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices·4,182 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years)...
Medical Devices·126 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>...
Medical Devices·5,232 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 yea...
Medical Devices·8,294 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolesc...
Medical Devices·2,991 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices·3,354 affected·Nov 10, 2023
High RiskFDA
Encore Medical, Lp
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR K...
Surgical Devices·37 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12...
Medical Devices·1,796 affected·Nov 10, 2023
High RiskFDA
Hans Kissle Company, Llc
Hans Kissle Potato Salad White Homestyle, 10 lb. bulk case, UPC Codes: 00036217701003
Produce·217 affected·Nov 9, 2023
High RiskFDA
Jeni's Splendid Ice Creams Llc
Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pint cups with heat seals and paper lids - 8 pints ...
Dairy·58,473 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuti...
Injectable Drugs·5,948 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, N...
Injectable Drugs·2,458 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceutical...
Injectable Drugs·909 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Ra...
Injectable Drugs·400 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ...
Injectable Drugs·324 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pha...
Injectable Drugs·1,259 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceutic...
Injectable Drugs·1,023 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Ph...
Injectable Drugs·10,017 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 R...
Injectable Drugs·5,079 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Ra...
Injectable Drugs·548 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceu...
Injectable Drugs·500 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Wi...
Injectable Drugs·1,122 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow...
Drugs·1,425 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rai...
Injectable Drugs·9,624 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE...
Injectable Drugs·412 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Phar...
Injectable Drugs·2,427 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceutic...
Injectable Drugs·256 affected·Nov 9, 2023