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CriticalFDA
Gregory's Foods, Inc
Gregory's Foods Bag Full of Cookies, White Chocolate Macadamia Nut, frozen cookie dough. Net Wt 2 lbs 8.5 oz (1148g). UPC 8 30825-0012...
Bakery & Grains·308 affected·Dec 19, 2025
RecallFDA
Zydus Pharmaceuticals (usa) Inc
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zyd...
Oral Drugs·2,136 affected·Dec 19, 2025
High RiskFDA
Novo Nordisk Inc.
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark,...
Injectable Drugs·0 affected·Dec 19, 2025
High RiskFDA
Novo Nordisk Inc.
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmar...
Injectable Drugs·0 affected·Dec 19, 2025
High RiskFDA
Sato Pharmaceutical Co., Ltd
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmac...
Oral Drugs·3,640 affected·Dec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Medical Devices·34 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Medical Implants·266 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Medical Implants·557 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Medical Implants·588 affected·Dec 19, 2025
High RiskFDA
Icu Medical, Inc.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Medical Devices·14,684,607 affected·Dec 19, 2025
High RiskFDA
Tyber Medical
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Numbe...
Medical Devices·64 affected·Dec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Medical Devices·98 affected·Dec 19, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices·2 affected·Dec 19, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices·2 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Medical Implants·39 affected·Dec 19, 2025
High RiskFDA
Icu Medical Inc.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Medical Devices·64,290 affected·Dec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Medical Devices·22 affected·Dec 19, 2025
High RiskFDA
Altruan Gmbh
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Medical Devices·188 affected·Dec 19, 2025
High RiskFDA
Direct Source Seafood Llc
waterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count per Lb. Net wt. 32oz (2LB). Product is packaged in ...
Seafood·1,800 affected·Dec 18, 2025
High RiskFDA
Catao Market Llc
Mini Gaceniga Authentic Cuban Loaf Cake Classic (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard...
Bakery & Grains·385 affected·Dec 18, 2025
High RiskFDA
Catao Market Llc
Gacen¿iga Authentic Cuban Loaf Cake Classic (Net Wt. 24 oz (680g)) packaged in wax paper, placed in clear bag and packed in cardboard car...
Bakery & Grains·775 affected·Dec 18, 2025
High RiskFDA
Direct Source Seafood Llc
MARKET 32 by Price Chopper brand, frozen RAW SHRIMP easy peel shell on 26/30 count per pound. Net 16oz. Product is packaged in a clear fl...
Seafood·32 affected·Dec 18, 2025
High RiskFDA
Catao Market Llc
Mini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard...
Bakery & Grains·260 affected·Dec 18, 2025
High RiskFDA
Imprimis Njof, Llc
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 W...
Injectable Drugs·314 affected·Dec 18, 2025
High RiskFDA
Imprimis Njof, Llc
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route ...
Injectable Drugs·596 affected·Dec 18, 2025
High RiskFDA
Imprimis Njof, Llc
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 7138...
Injectable Drugs·778 affected·Dec 18, 2025
High RiskFDA
Wilson-cook Medical Inc.
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model...
Medical Devices·153 affected·Dec 18, 2025
High RiskFDA
Community Products, Llc
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or...
Medical Devices·3,238 affected·Dec 18, 2025
High RiskFDA
Community Products, Llc
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facili...
Medical Devices·470 affected·Dec 18, 2025
High RiskFDA
Rovira Biscuit Corporation
Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022
Food·22,114 affected·Dec 17, 2025
High RiskFDA
Ziyad Brothers Importing
Baraka French Style Puff Pastry 1lb and 1.5lbs sizes, UPCs 8 22514 28540 3 and 8 22514 28550 2, both sizes 12 retail units per wholesale ...
Bakery & Grains·2,865 affected·Dec 17, 2025
RecallFDA
Prima Foods International, Inc.
BarbaCuban 455 Everything Sauce (Original), Net Wt 12 oz (355 ml) glass bottle and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE I...
Food·12,214 affected·Dec 17, 2025
High RiskFDA
Ziyad Brothers Importing
Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
Bakery & Grains·575 affected·Dec 17, 2025
RecallFDA
Prima Foods International, Inc.
BarbaCuban Havana Gold, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles. UPC code 7 19660 00097 7
Food·12,214 affected·Dec 17, 2025
High RiskFDA
Plant Based Innovations, Llc
HIGHER HARVEST by H-E-B brand; Dairy Free Coconut Based YOGURT; STRAWBERRY; YOGURT ALTERNATIVE; NET WT 5.3 OZ; INGREDIENTS: COCONUT MILK ...
Dairy·175 affected·Dec 17, 2025
RecallFDA
Prima Foods International, Inc.
BarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 1 gallon HDPE Industrial Plastic Jugs, ¿...
Food·12,214 affected·Dec 17, 2025
RecallFDA
Prima Foods International, Inc.
BarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDP...
Food·12,214 affected·Dec 17, 2025
RecallFDA
Prima Foods International, Inc.
BarbaCuban 90 Miles to Mojo Marinade, Net Wt 12 oz (355 ml) 12 oz glass bottles,1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Indu...
Food·12,214 affected·Dec 17, 2025
High RiskFDA
Rovira Biscuit Corporation
Tempting Crackers Tray, Rovira, 3 foil wrap trays per Net Wt. 8oz box (Net Wt 5 oz trays), 6 box per case. UPC 072981003127 Tempting Cra...
Bakery & Grains·9,838 affected·Dec 17, 2025
High RiskFDA
Rovira Biscuit Corporation
Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case. Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz...
Bakery & Grains·71,492 affected·Dec 17, 2025
High RiskFDA
Rovira Biscuit Corporation
Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per bo...
Bakery & Grains·6,671 affected·Dec 17, 2025
High RiskFDA
Rovira Biscuit Corporation
Vainilla Crackers, Great Value (Galletas Vainilla)8 Foil Packets (17 g each), Net Wt.9.6 oz (272 g) box, 6 boxes per case. UPC 072981005022
Bakery & Grains·16,478 affected·Dec 17, 2025
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFu...
Drugs·106,400 affected·Dec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
AlternatiV+ Screw-In Anchor
Medical Devices·416 affected·Dec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Genesis Push-In Suture Anchor
Medical Devices·200 affected·Dec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Fixone Biocomposite Anchor
Medical Devices·1,088 affected·Dec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Fixone Hybrid Anchor
Medical Devices·233 affected·Dec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Genesis Knotless Anchor
Medical Devices·1,163 affected·Dec 17, 2025