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High RiskFDA
Cardinal Health 200, Llc
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Medical Devices·940,203 affected·Nov 1, 2024
High RiskFDA
Legally Addictive Foods
LEGALLY ADDICTIVE THE O.G. COOKIES MADE FROM CRACKERS+TOFFEE+CHOCOLATE+SEA SALT NET WT. 4.7OZ (133G) UPC 8 54766 00802 8 & 1.34OZ (38G) ...
Bakery & Grains·0 affected·Oct 31, 2024
High RiskFDA
Curio Spice Co.
Curio Spice Co. brand Grains of Paradise (Korerima) - Jar 1.25 oz net wt. UPC: 672975171032
Food·760 affected·Oct 31, 2024
High RiskFDA
Noven Pharmaceuticals Inc
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a ...
Topical Drugs·685 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Medical Devices·70 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Medical Devices·56 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Medical Devices·2,537 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Medical Devices·10,129 affected·Oct 31, 2024
High RiskFDA
Cartiva, Inc
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Medical Implants·0 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Medical Devices·0 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Medical Devices·7,974 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Medical Devices·584 affected·Oct 31, 2024
High RiskFDA
Hermes Medical Solutions Ab
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Medical Devices·778 affected·Oct 31, 2024
High RiskFDA
Deseret Biologicals Inc
DesBio lunaSOMM Natural Sleep Support Dietary Supplement capsules, 30 count in a Blue PET bottle with a White cap. Supplement facts decl...
Supplements·2,547 affected·Oct 30, 2024
High RiskFDA
Baxter Healthcare Corporation
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solu...
Injectable Drugs·60,594 affected·Oct 30, 2024
High RiskFDA
Savencia Cheese Usa
Aldi Emporium Selection Brie 8oz UPC 4099100084016; 12 retail units per case La Bonne Vie Brie 8oz UPC 820581678531; 6 retail units per c...
Food·2,102 affected·Oct 29, 2024
High RiskFDA
Savencia Cheese Usa
Glenview Farms Spreadable Brie 2, 3lb tubs per case
Food·754 affected·Oct 29, 2024
High RiskFDA
R. Walters Foods, Limited Liability Corporation
Hannaford brand seafood salad; Net Wt. 12 oz. (340g); INGREDIENTS: SEAFOOD BLEND (FISH PROTEIN [ALASKA POLLOCK AND/OR PACIFIC WHITING], W...
Seafood·278 affected·Oct 29, 2024
High RiskFDA
Englewood Cannery
Traditional Country Canning Spaghetti Sauce, Net Wt. 16 oz. (453g), packaged in glass jars with metal lids, 12 jars per case
Food·240 affected·Oct 29, 2024
High RiskFDA
Savencia Cheese Usa
La Bonne Vie Camembert 8oz UPC 820581678616; 6 retail units per case
Food·70 affected·Oct 29, 2024
High RiskFDA
Viona Pharmaceuticals Inc
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceutical...
Topical Drugs·6,048 affected·Oct 29, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs·155,232 affected·Oct 29, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software V...
Medical Devices·92 affected·Oct 29, 2024
High RiskFDA
Microport Orthopedics Inc.
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE ...
Medical Implants·32 affected·Oct 29, 2024
High RiskFDA
Smith & Nephew Inc.
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Medical Devices·2,156 affected·Oct 29, 2024
High RiskFDA
Boston Scientific Corporation
AMS Artificial Urinary Sphincter Control Pump
Medical Devices·16 affected·Oct 28, 2024
High RiskFDA
Boston Scientific Corporation
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Medical Devices·52 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Medical Devices·10,223 affected·Oct 28, 2024
High RiskFDA
Noah Medical
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic...
Diagnostic Devices·18 affected·Oct 28, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Medical Devices·3 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Medical Devices·12,282 affected·Oct 28, 2024
High RiskFDA
Ge Medical Systems, Llc
Discovery MR750w 3.0T, whole body magnetic resonance scanner
Medical Devices·8 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Medical Devices·142,327 affected·Oct 28, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Medical Devices·53 affected·Oct 28, 2024
High RiskFDA
Mamtakim, Inc.
BELEVINI, DRIED FRUIT MIX (Apples, Pears & Plums w/pit), 500g, PLASTIC SOFT PACK, 6 PACKAGES PER CASE
Produce·109 affected·Oct 25, 2024
High RiskFDA
Lannett Company Inc.
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, ND...
Oral Drugs·1,608 affected·Oct 25, 2024
High RiskFDA
Noah Medical
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Medical Devices·26 affected·Oct 25, 2024
High RiskFDA
Unexo Life Sciences Private Limited
THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 7110...
Topical Drugs·279,936 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 ...
Topical Drugs·6,848,820 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Geor...
Topical Drugs·28,864 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101...
Topical Drugs·455,536 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), D...
Topical Drugs·363,300 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distribu...
Topical Drugs·1,101,600 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294...
Topical Drugs·10,368 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 894...
Topical Drugs·4,968,000 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
Topical Drugs·17,928 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 8947...
Topical Drugs·946,080 affected·Oct 24, 2024
High RiskFDA
Unexo Life Sciences Private Limited
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60...
Topical Drugs·10,368 affected·Oct 24, 2024