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High RiskFDA
Gold Star Distribution Inc
PEPCID COMPLETE - 25CT
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
DAYQUIL COLD & FLU, 32CT/2PK
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packe...
Oral Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Benadryl, 25'S 2PK Box, UPC 815556020316
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Cardinal Health 200, Llc
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardi...
Medical Devices·1,169,726 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTE...
Medical Devices·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) ...
Medical Devices·0 affected·Dec 26, 2025
High RiskFDA
Southern Rocklobster Ltd Usa
Australian Greenlip Abalone, Frozen, 9 pieces, Net Wt. 23.5 OZ UPC: 9335533013342
Frozen Food·94 affected·Dec 24, 2025
High RiskFDA
Medline Industries, Lp
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SW...
Medical Devices·7,380 affected·Dec 24, 2025
High RiskFDA
Zimmer Surgical Inc
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Versi...
Medical Devices·51 affected·Dec 24, 2025
High RiskFDA
Medline Industries, Lp
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medical Devices·450 affected·Dec 24, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm...
Cardiac Devices·364 affected·Dec 24, 2025
High RiskFDA
Zimmer Surgical Inc
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Versi...
Medical Devices·206 affected·Dec 24, 2025
High RiskFDA
Focalyx Technologies, Llc.
Focalyx Fusion
Medical Devices·18 affected·Dec 23, 2025
High RiskFDA
Baxter Healthcare Corporation
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-00...
Drugs·125,496 affected·Dec 22, 2025
High RiskFDA
Lsl Healthcare Inc.
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Medical Devices·1,400 affected·Dec 22, 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
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
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
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
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
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