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High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for main...
Medical Implants·124 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maint...
Medical Implants·231 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintain...
Medical Implants·77 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·199 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended f...
Medical Implants·6 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·115 affected·Aug 1, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-...
Oral Drugs·2,404 affected·Jul 31, 2024
High RiskFDA
Granules Pharmaceuticals Inc.
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactur...
Oral Drugs·11,808 affected·Jul 31, 2024
High RiskFDA
Inspire Medical Systems Inc.
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Respiratory Devices·152 affected·Jul 31, 2024
High RiskFDA
Beckman Coulter Inc.
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemist...
Diagnostic Devices·12,102 affected·Jul 31, 2024
High RiskFDA
Coopersurgical, Inc.
Stainless Steel Sims Uterine Sound, Part Number 64-601
Medical Devices·657 affected·Jul 31, 2024
High RiskFDA
Wr Coffee Inc
Ham and Cheese Croissant (approximately 6.5 oz) delivered fresh in bins to the firm's Restaurants- no label. Not individually packaged.
Dairy·90 affected·Jul 30, 2024
High RiskFDA
Colonna Brothers Inc.
Ground cinnamon. Supreme Tradition brand ground cinnamon packaged in 2.25 oz clear plastics jars with black lids. UPC: 639277656377 Ma...
Food·0 affected·Jul 30, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Diagnostic Devices·5,371 affected·Jul 30, 2024
High RiskFDA
El Chilar-hf, Llc
El Chilar, Canela Molida, Ground Cinnamon NET WT. 1.25 Oz (35g) , Spices Herbs, BOPP Bag, 12 units per cases
Food·54 affected·Jul 29, 2024
High RiskFDA
La Superior Bakery
La Superior Bakery - Pan De Rancho packaged in clear plastic bag - 5 pastries per bag
Food·11 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 41303.82013, Reser's Essential Everyday Original Potato Salad, refrigerated product, net wt. 16oz. There are 6 packs per case.
Produce·50 affected·Jul 29, 2024
High RiskFDA
La Superior Bakery
La Superior Bakery - Pan Guatemalteco packaged in clear plastic bag - 5 pastries per bag
Food·5 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.14459, Gravy Homestyle, refrigerated product, net wt. 4lb. There are 3 packs per case.
Food·144 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.02123, Reser's American Classics Macaroni & Cheese, refrigerated product, net wt. 12oz. There are 6 packs per case.
Dairy·18 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.15207, Reser's Raspberry Parfait Desserts, refrigerated product, net wt. 8lb. There are 2 packs per case.
Produce·18 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.03034, Reser's Kit HF Pudding Banana, refrigerated product, net wt. 4.81lb. There are 2 packs per case.
Food·6 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.10923, Reser's Smokehouse Potato Salad, refrigerated product, net wt. 5lbs. There are 2 packs per case.
Produce·7 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.56013, Reser's Sweet Corn with Butter, refrigerated product, net wt. 4lb. There are 4 packs per case.
Dairy·104 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.02009, Reser's American Classics Macaroni & Cheese White Cheddar, refrigerated product, net wt. 12oz. There are 6 packs per case.
Dairy·12 affected·Jul 29, 2024
High RiskFDA
Mamtakim, Inc.
Scortisoara macinata/ Ground cinnamon, 15 g, Paper cartons, 20 pieces per paper carton
Food·30 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.02008, Reser's American Classics Scalloped Potatoes, refrigerated product, net wt. 12oz. There are 6 packs per case.
Food·12 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.18531, Stonemill Kitchens Green Goddess Pasta Salad, refrigerated product, net wt. 5lb. There are 2 packs per case.
Produce·29 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.02126, Reser's American Classics Asiago Creamed Spinach, refrigerated product, net wt. 12oz. There are 6 packs per case.
Produce·12 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.11356, Reser's American Classics Egg Salad, refrigerated product, net wt. 12oz. There are 6 packs per case.
Produce·42 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.14378, Baked Scalloped Potatoes Special Request, refrigerated product, net wt. 2.5lb. There are 8 packs per case.
Food·60 affected·Jul 29, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Medical Devices·1,164 affected·Jul 29, 2024
High RiskFDA
Agfa N.v.
DR 800. Digital Radiography X-ray System.
Medical Devices·141 affected·Jul 29, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Medical Devices·143 affected·Jul 29, 2024
High RiskFDA
Eugia Us Llc
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, N...
Injectable Drugs·17,136 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
Medical Devices·880 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
Medical Devices·98 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Medical Devices·82 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Medical Devices·56 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Medical Devices·14 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
Medical Devices·659 affected·Jul 26, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human se...
Diagnostic Devices·0 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
Medical Devices·444 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;
Medical Devices·80 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;
Medical Devices·66 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
Medical Devices·332 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
Medical Devices·1,338 affected·Jul 26, 2024
High RiskFDA
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
Medical Devices·6 affected·Jul 26, 2024