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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·3,671 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmac...
Injectable Drugs·399 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rai...
Injectable Drugs·1,508 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd...
Injectable Drugs·381 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL U...
Injectable Drugs·613 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA ...
Injectable Drugs·33,072 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL US...
Injectable Drugs·130 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only...
Injectable Drugs·5,734 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT ...
Injectable Drugs·368 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, ...
Injectable Drugs·5,392 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pha...
Injectable Drugs·7,198 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 75...
Injectable Drugs·8,755 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pha...
Injectable Drugs·1,118 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Wi...
Injectable Drugs·500 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL US...
Injectable Drugs·242 affected·Nov 9, 2023
High RiskFDA
Family Medical Supply Inc
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supp...
Drugs·26,657 affected·Nov 9, 2023
High RiskFDA
Frito-lay, Inc. Headquarters
Chickpea Veggie Crisps, Net Wt. 6 1/4 oz (177.1g), UPC: 02840020646
Food·16,100 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 3...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - AR...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BR...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF ...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD56...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 ...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 ...
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Medical Devices·236,793 affected·Nov 8, 2023
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India,...
Oral Drugs·0 affected·Nov 7, 2023
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, In...
Oral Drugs·37,200 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduc...
Surgical Devices·2,551 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter int...
Surgical Devices·1 affected·Nov 7, 2023
High RiskFDA
Ge Hangwei Medical Systems, Co. Ltd
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Tabl...
Diagnostic Devices·68 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0...
Surgical Devices·717 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·0 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter int...
Surgical Devices·3 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·1,784 affected·Nov 7, 2023
High RiskFDA
Ge Hangwei Medical Systems, Co. Ltd
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Tabl...
Diagnostic Devices·134 affected·Nov 7, 2023
High RiskFDA
Medtronic Xomed, Inc.
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ...
Medical Devices·80,569 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the b...
Surgical Devices·4 affected·Nov 7, 2023
High RiskFDA
United Packers, Llc
Diet Coke packaged in 12oz aluminum cans - 12 pack fridge pack
Food·417 affected·Nov 6, 2023
High RiskFDA
United Packers, Llc
Sprite packaged in 12oz aluminum cans - 12 pack fridge pack
Food·1,557 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC21...
Surgical Devices·717 affected·Nov 6, 2023
High RiskFDA
Sarnova Hc, Llc
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professional...
Medical Devices·15 affected·Nov 6, 2023
High RiskFDA
Physio-control, Inc.
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Cardiac Devices·18,732 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Surgical Devices·59 affected·Nov 6, 2023
High RiskFDA
Maquet Medical Systems Usa
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorpore...
Cardiac Devices·1,595 affected·Nov 6, 2023