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High RiskFDA
Kenil Healthcare Private Limited
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distribute...
Topical Drugs·9,336 affected·Apr 24, 2025
High RiskFDA
Kenil Healthcare Private Limited
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Di...
Topical Drugs·11,808 affected·Apr 24, 2025
High RiskFDA
Kenil Healthcare Private Limited
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. ...
Topical Drugs·383,904 affected·Apr 24, 2025
High RiskFDA
Kenil Healthcare Private Limited
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, ...
Topical Drugs·10,128 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Medical Devices·25 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Diagnostic Devices·60 affected·Apr 24, 2025
High RiskFDA
Mobius Mobility Llc
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Medical Devices·442 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Diagnostic Devices·4 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Medical Devices·100 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Medical Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Diagnostic Devices·5 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Medical Devices·100 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Diagnostic Devices·400 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Medical Devices·1 affected·Apr 24, 2025
CriticalFDA
Baxter Healthcare Corporation
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Medical Devices·34,524 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Diagnostic Devices·2 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Diabetes Devices·4 affected·Apr 24, 2025
High RiskFDA
Better Business...better Foods, Inc.
New England Village Snacks The 19th Hole Snack Mix (5 oz. and 10 oz.)
Snacks & Candy·18,000 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Cinnamon Raisin Bagels: Gluten-free cinnamon raisin bagels, clear plastic bag, 16 oz, 4 bagels/package Ingredients: White rice flour, W...
Beverages·25 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Frosted Sugar Cookie: Gluten-free frosted sugar cookies, clear plastic bag, 4 oz, 6 cookies/package Ingredients: White rice flour, Powd...
Dairy·50 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Multigrain Bagels: Gluten-free multigrain bagels, clear plastic bag, 16 oz, 4 bagels/package Ingredients: White rice flour, Water, Egg ...
Beverages·25 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Artisan Cinnamon Raisin Bread: Gluten-free cinnamon raisin bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White ...
Bakery & Grains·42 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Artisan White Bread: Gluten-free artisan white bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour,...
Bakery & Grains·41 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Dye-Free Frosted Sugar Cookie: Gluten-free dye-free frosted sugar cookies, clear plastic bag, 4 oz, 6 cookies/package Ingredients: Whit...
Dairy·200 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Brownie Chocolate Chip Cookie: Gluten-free brownie chocolate chip cookies, clear plastic bag, 4 oz, 8 cookies/package Ingredients: Suga...
Dairy·50 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Artisan Multigrain Bread: Gluten-free multigrain bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flou...
Bakery & Grains·41 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Coconut Macaroon Cookie: Gluten-free coconut macaroon cookies, clear plastic bag, 4 oz, 6 cookies/package Ingredients: Coconut flakes, ...
Dairy·50 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Plain Bagels: Gluten-free plain bagels, clear plastic bag, 16 oz, 4 bagels/package Ingredients: White rice flour, Water, Egg whites, Ta...
Beverages·25 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Artisan Sourdough Bread: Gluten-free sourdough bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour,...
Bakery & Grains·42 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Seasoned Bread Crumbs: Gluten-free seasoned bread crumbs, vacuum-sealed clear plastic, 8 oz, bulk Ingredients: White rice flour, Water,...
Dairy·42 affected·Apr 23, 2025
High RiskFDA
East Ck Trading Inc.
PRESIDENT BRAND; Kumquat Slices; NET WT. 8 OZ/227g; EAST CK TRADING INC.; INGREDIENTS: Kumquat slices; packaged in clear plastic jars wit...
Food·775 affected·Apr 23, 2025
CriticalFDA
New Grains Gluten Free Bakery
Pecan Caramel Bars Individually wrapped in plastic. Ingredients: White rice flour, Sugar, Honey, Pecan pieces, Butter, Eggs, Rice milk, ...
Dairy·25 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 F...
Ophthalmic Drugs·13,872 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile...
Topical Drugs·1,610 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed ...
Ophthalmic Drugs·14,333 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moist...
Ophthalmic Drugs·13,104 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturi...
Ophthalmic Drugs·32,876 affected·Apr 23, 2025
RecallFDA
Beckman Coulter Ireland, Inc.
Apo B Reagent, REF: OSR6143
Diagnostic Devices·2,747 affected·Apr 23, 2025
High RiskFDA
Virtual Incision Corporation
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Surgical Devices·3 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Diagnostic Devices·231 affected·Apr 23, 2025