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High RiskFDA
Vantive Us Healthcare Llc
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Medical Devices·4,772 affected·Jul 28, 2025
High RiskFDA
Vantive Us Healthcare Llc
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Medical Devices·7,432 affected·Jul 28, 2025
High RiskFDA
Ortoma Ab
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapt...
Medical Implants·261 affected·Jul 28, 2025
High RiskFDA
Dollar General Corporation
Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old...
Beverages·84,240 affected·Jul 27, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
Food·74,654 affected·Jul 25, 2025
High RiskFDA
Gelsons
Gelson's Hummus; Red Bell Pepper Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10262
Food·7,861 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
Food·29,180 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
Food·47,065 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
Food·42,488 affected·Jul 25, 2025
High RiskFDA
Distinctive Foods Llc
Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers net wt 5.5oz. UPC 7 13733 00048 2
Bakery & Grains·1,790 affected·Jul 25, 2025
High RiskFDA
Gelsons
Gelson's Hummus; Low Sodium No Cholesterol Classic NET WT 10OZ (283g) UPC: 23631-10260
Food·7,861 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
Food·2,241 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
Food·70,044 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7
Food·12,163 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
Food·643,519 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
Produce·62,864 affected·Jul 25, 2025
High RiskFDA
Gelsons
Gelson's Hummus; Mediterranean Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10261
Food·7,861 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
Produce·33,105 affected·Jul 25, 2025
High RiskFDA
Gelsons
Gelson's Tzatziki; Old-World Family Recipe Real Greek Yogurt California-Made; NET WT. 8OZ (226g) UPC: 23631-10268
Dairy·7,861 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
Food·11,274 affected·Jul 25, 2025
High RiskFDA
Tropicale Foods, Llc
La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5
Dairy·15,001 affected·Jul 25, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., M...
Oral Drugs·1,856 affected·Jul 25, 2025
High RiskFDA
Alembic Pharmaceuticals Limited
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Guj...
Oral Drugs·9,492 affected·Jul 25, 2025
High RiskFDA
Olympus Corporation Of The Americas
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number:...
Surgical Devices·155 affected·Jul 25, 2025
High RiskFDA
Zap Surgical Systems
ZAP-X Radiosurgery System, Model: 300150
Medical Devices·17 affected·Jul 25, 2025
High RiskFDA
Merit Medical Systems, Inc.
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 ...
Diagnostic Devices·447 affected·Jul 25, 2025
High RiskFDA
The Bonami Baking Company, Inc.
Cheddar Bagel --- Ingredient Declaration: Harvest King Flour, All purpose flour, kosher salt, light brown sugar, yeast, water, malt, ched...
Dairy·6,156 affected·Jul 24, 2025
High RiskFDA
The Bonami Baking Company, Inc.
Whole Wheat Chocolate Croissants --- Ingredients: Whole White Wheat Flour, Enriched Wheat Flour (Unbleached Wheat Flour, Malted Barley Fl...
Dairy·351 affected·Jul 24, 2025
High RiskFDA
The Bonami Baking Company, Inc.
Wheat Hamburger Buns --- Ingredient Declaration: Water, Whole Wheat Flour, Enriched Wheat Flour (Unbleached Wheat Flour, Malted Barley Fl...
Dairy·61,862 affected·Jul 24, 2025
High RiskFDA
Superior Foods Company
Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in plastic tub UPC 4061462440151
Food·19,368 affected·Jul 24, 2025
High RiskFDA
The Bonami Baking Company, Inc.
Chocolate Croissants --- Ingredients: HARVEST KING FLOUR, Butter, Water, Sugar, Yeast, Salt, Chocolate Chips (Sugar, Chocolate, Butter
Dairy·21,096 affected·Jul 24, 2025
High RiskFDA
The Bonami Baking Company, Inc.
Whole Grain Par Baked Jalapeno Cheddar Bagel --- Ingredient Declaration: Whole White Wheat Flour, Enriched Flour (Unbleached Wheat Flour,...
Dairy·192 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The No...
Medical Devices·2 affected·Jul 24, 2025
High RiskFDA
Dentsply Ih, Inc.
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis...
Medical Implants·780 affected·Jul 24, 2025
High RiskFDA
Dentsply Ih, Inc.
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product...
Medical Implants·102 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and No...
Medical Devices·55 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The No...
Medical Devices·1 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoT...
Medical Devices·80 affected·Jul 24, 2025
High RiskFDA
Jagpreet Enterprises, Llc. Dba Sukhi's Gourmet Indian Foods
Sukhi's, TIKKA MASALA INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00163-0, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER ...
Food·4,869 affected·Jul 23, 2025
High RiskFDA
Jagpreet Enterprises, Llc. Dba Sukhi's Gourmet Indian Foods
Sukhi's TIKKA MASALA CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-105, UPC 7-67226-01005-2, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Food·9,930 affected·Jul 23, 2025
High RiskFDA
Jagpreet Enterprises, Llc. Dba Sukhi's Gourmet Indian Foods
Sukhi's, CLASSIC CURRY INDIAN CURRY SAUCE, NET WT 3 OZ., UPC 7-67226-00165-4, DISTRIBUTED BY: SUKHI'S GOURMET INDIAN FOODS 25823 CLAWITER...
Food·1,125 affected·Jul 23, 2025
High RiskFDA
Jagpreet Enterprises, Llc. Dba Sukhi's Gourmet Indian Foods
Sukhi's CLASSIC CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-101, UPC: 7-67226-01001-4, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Food·5,030 affected·Jul 23, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG9010...
Medical Devices·4 affected·Jul 23, 2025
High RiskFDA
Breadbox Co.
Breadman Bakery; Multigrain 24oz. Baked for Breaman-Melrose Bakery Inc. UPC# 8 6000947952 4
Bakery & Grains·52 affected·Jul 22, 2025
High RiskFDA
Martin Bauer, Inc.
Passionflower Herb Powdered Extract 4%, bulk packaging, individual large box, corrugated cardboard box with plastic liner .
Food·775 affected·Jul 22, 2025
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Injectable Drugs·382,775 affected·Jul 22, 2025
High RiskFDA
Taizhou Kangping Medical Science And Technology Co., Ltd.
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Profes...
Drugs·3 affected·Jul 22, 2025
High RiskFDA
Trinity Biotech Usa
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past ...
Diagnostic Devices·968 affected·Jul 22, 2025