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High RiskFDA
Vortex Surgical Inc.
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intu...
Medical Devices·14,789 affected·Dec 16, 2025
High RiskFDA
Whitewave - Louisville Pilot Plant
So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert, One Pint (473 mL). UPC 744473 476138. Manufactured B...
Dairy·4,665,608 affected·Dec 15, 2025
RecallFDA
Novadoz Pharmaceuticals Llc
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distr...
Oral Drugs·0 affected·Dec 15, 2025
CriticalFDA
Stuffbynainax
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Oral Drugs·4 affected·Dec 15, 2025
High RiskFDA
Immunotech A.s.
Estrone RIA, REF: DSL8700
Medical Devices·160 affected·Dec 15, 2025
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Medical Devices·41,526 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10F; Model Number: 722002;
Medical Devices·12 affected·Dec 15, 2025
CriticalFDA
Sunmed Holdings, Llc
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applic...
Medical Devices·20,583 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722027;
Medical Devices·22 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Number: 722028;
Medical Devices·2 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Product Name: Allura Xper FD10C; Model number: 722001;
Medical Devices·38 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10; Model Number: 722003;
Medical Devices·93 affected·Dec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Medical Devices·0 affected·Dec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Medical Devices·0 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722011;
Medical Devices·21 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20; Model Number: 722038;
Medical Devices·8 affected·Dec 15, 2025
High RiskFDA
Leaseir Technologies Slu
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: Th...
Surgical Devices·2 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722005;
Medical Devices·14 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Number: 722012;
Medical Devices·79 affected·Dec 15, 2025
High RiskFDA
Diagnostica Stago, Inc.
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum...
Medical Devices·438 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/10; Model Number: 722029;
Medical Devices·4 affected·Dec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Medical Devices·0 affected·Dec 15, 2025
High RiskFDA
D. Coluccio & Sons Inc.
Sapori Amaretti Almonds 175 g Cookies
Bakery & Grains·800 affected·Dec 14, 2025
RecallUSDA
La Guadalupana
La Guadalupana Foods LLC Recalls Ready-To-Eat Frozen Tamales Due to Misbranding and an Undeclared Allergen
Pork·0 affected·Dec 14, 2025
High RiskFDA
Tom Bumble Llc
Tom Bumble Nutty Peanut Butter Flake Candy with Peanut & Chocolate GF V. Product is shelf stable, gold foil wrapping with paper label and...
Dairy·6,500 affected·Dec 13, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Mushroom, Spinach & Salsa Tamales with 2 Cheeses Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Onions, Jalapenos, Jack and W...
Dairy·25,889 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Roasted Green Chile & Jack Cheese Tamales Ingredients: Organic Corn Flour Masa, Roasted Green Chiles, Jack Cheese (Pasteurized Milk, Che...
Dairy·31,672 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Butternut Squash Tamales with Roasted Green Chiles, NO DAIRY Ingredients: Organic Corn Flour Masa, Organic Butternut Squash, Roasted Gre...
Dairy·18,876 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Butternut Squash Tamales With Roasted Green Chiles, Corn & Jack Cheese Ingredients: Organic Corn Flour Masa, Organic Butternut Squash, O...
Dairy·30,327 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Black Bean Bonanza Tamales with Black Beans and Jack Cheese Ingredients: Organic Corn Flour Masa, Black Beans, Jack Cheese (Pasteurized ...
Dairy·26,457 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Black Bean Bonanza Tamales with Black Beans NO DAIRY Ingredients: Organic Corn Flour Masa, Black Beans, Salsa (Tomatoes, Onions, Chiles,...
Dairy·16,790 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Roasted Green Chile Tamales NO DAIRY Ingredients: Organic Corn Flour Masa, Roasted Green Chiles, Non-GMO Corn, Non-hydrogenated Vegetabl...
Dairy·21,705 affected·Dec 12, 2025
CriticalFDA
South Asian Food Inc.
Bengal King Jhal Chanachur food treats 12.34oz (350gm)
Food·95 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
BBQ Chipotle Bean & White Cheddar Tamales Ingredients: Organic Corn Flour Masa, Beans, Jack Cheese (Pasteurized Milk, Cheese Cultures, S...
Dairy·27,964 affected·Dec 12, 2025
High RiskFDA
House Of Flavors, Inc.
1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6
Dairy·2,388 affected·Dec 12, 2025
High RiskFDA
Prima Vera Nueva, Inc.
Mushroom, Spinach & Salsa Tamales No Dairy Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Tomatoes, Onions, Jalapenos, Non-hy...
Dairy·16,264 affected·Dec 12, 2025
High RiskFDA
House Of Flavors, Inc.
2248 Banana Pudding Ice Cream, 3 GAL, UPC 7 65265 81237 8
Dairy·34,561 affected·Dec 12, 2025
CriticalFDA
Medinatura New Mexico, Inc.
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquer...
Inhaled / Nasal Drugs·0 affected·Dec 12, 2025
High RiskFDA
Merck Sharp & Dohme Llc
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07...
Oral Drugs·3 affected·Dec 12, 2025
CriticalFDA
Medinatura New Mexico, Inc.
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4...
Inhaled / Nasal Drugs·0 affected·Dec 12, 2025
High RiskFDA
Merck Sharp & Dohme Llc
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Shar...
Oral Drugs·845 affected·Dec 12, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitori...
Medical Devices·1,301 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU ...
Medical Devices·117 affected·Dec 12, 2025
High RiskFDA
Elekta, Inc.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description...
Medical Devices·0 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medical Devices·0 affected·Dec 12, 2025
High RiskFDA
Bard Peripheral Vascular Inc
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Surgical Devices·14,935 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion system; Software Version Number: R3.1;
Medical Devices·228 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit ...
Medical Devices·1,928 affected·Dec 12, 2025