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High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323...
Injectable Drugs·4,411 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of r...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: inte...
Medical Devices·81 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H31...
Medical Devices·52 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/tr...
Diagnostic Devices·113 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·1,759 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·24 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·247 affected·Dec 10, 2020
High RiskFDA
Remel Inc
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Medical Devices·637 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curv...
Surgical Devices·863 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioiso...
Medical Devices·7 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Medical Devices·583 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/C...
Medical Devices·187 affected·Dec 10, 2020
High RiskFDA
Sentec Ag
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of ...
Respiratory Devices·15 affected·Dec 10, 2020
High RiskFDA
Accuray Incorporated
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of ra...
Medical Devices·8 affected·Dec 10, 2020
High RiskFDA
Biogen Ma Inc.
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufacture...
Oral Drugs·5,307 affected·Dec 9, 2020
High RiskFDA
Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc
Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC....
Oral Drugs·2,170 affected·Dec 9, 2020
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (47...
Oral Drugs·127,392 affected·Dec 9, 2020
High RiskFDA
Riverpoint Medical, Llc
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Medical Devices·3,060 affected·Dec 9, 2020
High RiskFDA
Becton Dickinson & Company
BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a...
Medical Devices·105,880 affected·Dec 9, 2020
High RiskFDA
Shilpa Medicare Limited
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufac...
Injectable Drugs·35,931 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharma...
Oral Drugs·4,166 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufac...
Injectable Drugs·6,560 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufacture...
Injectable Drugs·2,008 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic...
Injectable Drugs·2,064 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharma...
Oral Drugs·2,611 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to...
Medical Devices·103,475 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·34,825 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to...
Medical Devices·60,425 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging t...
Medical Devices·31,900 affected·Dec 8, 2020
High RiskFDA
Philips Home Healthcare Solution
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Diagnostic Devices·91 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a...
Surgical Devices·3,858 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component o...
Surgical Devices·3,165 affected·Dec 8, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex Loss of Resistance Device, REF 100/398/000
Medical Devices·3,420 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of...
Surgical Devices·1,926 affected·Dec 8, 2020
High RiskFDA
The Magstim Company Limited
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cran...
Surgical Devices·7 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·0 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·34,650 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·69,275 affected·Dec 8, 2020
CriticalFDA
Avkare Inc.
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Oral Drugs·14,368 affected·Dec 7, 2020
High RiskFDA
Avkare Inc.
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Oral Drugs·38,715 affected·Dec 7, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial ND...
Injectable Drugs·1,324,072 affected·Dec 7, 2020
High RiskFDA
Oto Med Inc
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a sucti...
Medical Devices·5,092 affected·Dec 7, 2020
High RiskFDA
Carl Zeiss Meditec Ag
IOLMaster 700
Medical Devices·613 affected·Dec 7, 2020
CriticalFDA
Market Of Choice Inc
Market of Choice brand Sour Cherry Baked Brie is wrapped in a plastic shrink wrap and has a white adhesive store label. UPC 0 217241 4149...
Dairy·444 affected·Dec 4, 2020
RecallFDA
Hs Baking Enterprises Llc Dba Darlington Manufacturing
Darlington's Soft Baked Cookies, Sugar Free Net Wt. 0.75 oz (21 g), Darlington, Noblesville, IN
Bakery & Grains·503 affected·Dec 4, 2020
CriticalFDA
Treehouse Foods
HOUSE RECIPE HONEY MUSTARD DRESSING & DIP NET WT 1 OZ.(28g) cup CONTAINS: EGGS DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077 UPC...
Food·511 affected·Dec 3, 2020