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High RiskFDA
Welch Allyn, Inc/mortara
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM I...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Sc...
Diagnostic Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT ...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under ...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-le...
Diagnostic Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
Cardiac Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·2,500 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Medical Devices·21 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Medical Devices·269 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Medical Devices·12 affected·Mar 17, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Medical Devices·125,196 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·1,929 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Medical Devices·32,760 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Medical Devices·5 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Medical Devices·4,320 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Medical Devices·1,314 affected·Mar 17, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The dev...
Medical Devices·8,170 affected·Mar 17, 2020
High RiskFDA
Becton Dickinson & Company
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Surgical Devices·655 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·700 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·34,785 affected·Mar 17, 2020
High RiskFDA
Rayner Intraocular Lenses Limited
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to b...
Medical Devices·2,425 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·16,393 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·9,137 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·2,698 affected·Mar 17, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Oral Drugs·446,628 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 7...
Injectable Drugs·2,475 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave....
Injectable Drugs·1,500 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis ...
Injectable Drugs·900 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tr...
Oral Drugs·471,024 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Conges...
Drugs·566 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject ...
Injectable Drugs·290 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road D...
Injectable Drugs·75 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium...
Injectable Drugs·1,840 affected·Mar 16, 2020
High RiskFDA
The Medicine Shoppe Pharmacy
Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
Drugs·4 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis ...
Injectable Drugs·1,350 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. D...
Injectable Drugs·1,075 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Fr...
Injectable Drugs·4,625 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC ...
Injectable Drugs·80 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, L...
Drugs·210 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 01...
Topical Drugs·4,104 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Da...
Injectable Drugs·375 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-3...
Injectable Drugs·2,250 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0...
Oral Drugs·151,056 affected·Mar 16, 2020
High RiskFDA
Avanos Medical, Inc.
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Medical Devices·1,766 affected·Mar 16, 2020
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Ca...
Medical Devices·66 affected·Mar 16, 2020
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens,...
Medical Devices·35 affected·Mar 16, 2020
High RiskFDA
Winco Foods Llc
WinCo Foods frozen Berry Medley (Strawberries, Blackberries, Raspberries and Blueberries), item# 107412, packaged in polyethylene bags. P...
Produce·21,264 affected·Mar 13, 2020
High RiskFDA
Raw Seafoods Inc.
Food You Feel Good About Brand, Salmon Teriyaki, Oven Safe
Seafood·762 affected·Mar 13, 2020