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High RiskFDA
Angiodynamics, Inc.
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to meas...
Medical Devices·60 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing a...
Respiratory Devices·21 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at...
Respiratory Devices·3 affected·Nov 19, 2019
High RiskFDA
Nectar Foods Inc.
Honey Mama s Truffle Bar (Trader Joe's) is a honey cocoa bar, refrigerated, one bar is packaged in flexible film, flow wrapped, net weigh...
Dairy·6,696 affected·Nov 18, 2019
High RiskFDA
Stern Produce Company Inc.
Queen Victoria Sweet Baby Broccoli from Ippolito International, packed in ice in half bushel boxes, 18 count bunches/case, pack date of N...
Baby Food & Formula·20 affected·Nov 18, 2019
High RiskFDA
Honey Heaven Wholesale Inc
Hummingbird Wholesale Organic Chia Seeds, SD120-5#, packaged in a clear plastic bag with a while label, net wt. 5 lbs. No UPC code.
Food·10 affected·Nov 18, 2019
High RiskFDA
Viewray, Inc.
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS)...
Medical Devices·32 affected·Nov 18, 2019
High RiskFDA
Leica Microsystems, Inc.
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detect...
Diagnostic Devices·558 affected·Nov 18, 2019
High RiskFDA
Raysearch Laboratories Ab
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 ...
Medical Devices·956 affected·Nov 18, 2019
RecallFDA
Livanova Usa Inc.
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Medical Devices·140 affected·Nov 18, 2019
High RiskFDA
Boston Scientific Corporation
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and a...
Medical Devices·139 affected·Nov 18, 2019
High RiskFDA
Boston Scientific Corporation
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and a...
Medical Devices·179 affected·Nov 18, 2019
High RiskFDA
Diagnostica Stago, Inc.
STA SYSTEM CONROL N + P (ref. 00678)
Medical Devices·5,437 affected·Nov 18, 2019
High RiskFDA
The Kraft Heinz Company
Breakstones 4% Milkfat Small Curd Cottage Cheese, in 24 oz. Plastic Tub, with UPC 0 21000 12284 4, 12 packages per case
Dairy·3,467 affected·Nov 15, 2019
High RiskFDA
Kraft Foods Global Inc
CHEESE NIPS (11 oz. BOX), Retail UPC - 0 44000 03453 5, Best When Used By Date - 18MAY20, 19MAY20, 20MAY20
Dairy·9,007 affected·Nov 15, 2019
RecallFDA
Sara Lee Frozen Foods
Chef Pierre 37 Ounce Pumpkin Spice Latte Pie, in foil pie pan with dome lid, frozen, 4 pies per wholesale case, with SKU number 09368 and...
Frozen Food·990 affected·Nov 15, 2019
High RiskFDA
The Kraft Heinz Company
Breakstones 4% Milkfat Large Curd Cottage Cheese, in 24 oz. Plastic Tub, with UPC 0 21000 12285 1, 12 packages per case
Dairy·3,139 affected·Nov 15, 2019
High RiskFDA
The Kraft Heinz Company
Breakstones 2% Milkfat Lowfat Large Curd Cottage Cheese, in 16 oz. Plastic Tub, with UPC 0 21000 30053 2, 12 packages per case
Dairy·2,883 affected·Nov 15, 2019
RecallFDA
Rising Pharmaceuticals, Inc.
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharma...
Topical Drugs·0 affected·Nov 15, 2019
High RiskFDA
Akorn, Inc.
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: ...
Oral Drugs·4,206 affected·Nov 15, 2019
RecallFDA
Rising Pharmaceuticals, Inc.
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc...
Topical Drugs·15,072 affected·Nov 15, 2019
RecallFDA
Grato Holdings, Inc.
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, N...
Drugs·659 affected·Nov 15, 2019
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glen...
Drugs·34,521 affected·Nov 15, 2019
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, M...
Drugs·480 affected·Nov 15, 2019
CriticalFDA
Tytek Medical Inc
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the remov...
Medical Devices·3,565 affected·Nov 15, 2019
CriticalFDA
Arrow International Inc
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Surgical Devices·1 affected·Nov 15, 2019
CriticalFDA
Arrow International Inc
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Surgical Devices·71 affected·Nov 15, 2019
High RiskFDA
Baxter Healthcare Corporation
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Medical Devices·101,976 affected·Nov 15, 2019
High RiskFDA
Avkare Inc.
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of...
Oral Drugs·631,138 affected·Nov 14, 2019
High RiskFDA
Avkare Inc.
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30...
Oral Drugs·104,797 affected·Nov 14, 2019
High RiskFDA
Wisconsin Pharmacal Company, Llc
Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) ...
Drugs·44,373 affected·Nov 14, 2019
High RiskFDA
Abbott Diabetes Care, Inc.
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Diabetes Devices·0 affected·Nov 14, 2019
High RiskFDA
Cardinal Health Inc.
Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expandi...
Medical Implants·267,247 affected·Nov 14, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Medical Devices·3 affected·Nov 14, 2019
High RiskFDA
Abbott Diabetes Care, Inc.
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Diabetes Devices·0 affected·Nov 14, 2019
High RiskFDA
Precision Dose Inc.
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case,...
Oral Drugs·224,940 affected·Nov 13, 2019
CriticalFDA
Natures Rx
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per c...
Oral Drugs·2,800 affected·Nov 13, 2019
High RiskFDA
Getinge Us Sales Llc
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Respiratory Devices·3,633 affected·Nov 13, 2019
High RiskFDA
Linet Spol. S.r.o.
Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product U...
Medical Devices·518 affected·Nov 13, 2019
High RiskFDA
Medtronic Xomed, Inc.
Lamicel 10PK 10MM INTL
Medical Devices·10 affected·Nov 13, 2019
High RiskFDA
Ac Culinary Group Llc.
Chef Pineiro's Ajo con Cilantro, with Coriander, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g)
Food·14,088 affected·Nov 12, 2019
CriticalFDA
Simplot-rdo Llc
Simplot simple goodness Classic Mixed Vegetables, foodservice item. There are 12/2.5 lbs. clear plastic bags per case. SKU #: 10071179 1...
Produce·142 affected·Nov 12, 2019
High RiskFDA
Ac Culinary Group Llc.
Chef Pineiro's Sofrito con Albahaca, with Basil, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g)
Food·13,440 affected·Nov 12, 2019
High RiskFDA
Ac Culinary Group Llc.
Chef Pineiro's Ajo con Albahaca, with Basil, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g)
Food·12,000 affected·Nov 12, 2019
High RiskFDA
Ac Culinary Group Llc.
Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g)
Food·23,040 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Su...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX ...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7747...
Drugs·0 affected·Nov 12, 2019