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High RiskFDA
Sklar Instruments
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SC...
Medical Devices·350 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Surgical Devices·150 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO ST...
Medical Devices·7,730 affected·Dec 3, 2024
High RiskFDA
Remedyrepack Inc.
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx on...
Oral Drugs·1,564 affected·Dec 2, 2024
High RiskFDA
Coloplast Manufacturing Us, Llc
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, A...
Surgical Devices·36,369 affected·Dec 2, 2024
High RiskFDA
A L I Technologies Ltd
Change Healthcare Cardiology Hemo software
Medical Devices·204 affected·Dec 2, 2024
High RiskFDA
Microvention Inc.
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Surgical Devices·107 affected·Dec 2, 2024
High RiskFDA
Accriva Diagnostics, Inc.
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Medical Devices·25 affected·Dec 2, 2024
High RiskFDA
A L I Technologies Ltd
McKesson Cardiology Hemo software
Medical Devices·1 affected·Dec 2, 2024
High RiskFDA
Moximed, Inc.
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Medical Implants·115 affected·Dec 2, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container b.) King Kullen brand Tropical Fruit Cup; UPC: 85316-...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Diced Red Onion; UPC: 85316-10086; 12 oz plastic container b.) Wild By Nature brand Diced Red Onion; UPC: 85316-100...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic container b.) Wild By Nature brand Fiesta Bowl; UPC: 85316-10201; 64 o...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) Gracie's Kitchen brand Broccoli & Cauliflower Florets; UPC: 85316-1009; 12 oz foam tray
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) Gracie's Kitchen brand Cauliflower Florets; UPC: 85316-10012; 12 oz foam tray
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Fiesta Watermelon Bowl; UPC: 85316-10200; 60 oz plastic container b.) Gracie's Kitchen brand Fiesta Watermelon Bowl...
Beverages·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) Gracie's Kitchen brand Broccoli Florets; UPC: 85316-10011; 12 oz foam tray
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container b.) Gracie's Kitchen brand Watermelon Halo; UPC: 85316-1...
Beverages·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Cantaloupe Slices; UPC 85316-10008; 20 oz foam tray b) Wild By Nature brand Cantaloupe Slices; UPC: 85316-10008; 20...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Tropical Delight Bowl; UPC: 85316-10391; 28 oz plastic container b.) Gracie's Kitchen brand Tropical Delight Bowl; ...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Watermelon Slices; UPC 85316-10006; 20 oz foam tray b) Wild By Nature brand Watermelon Slices; UPC: 85316-10006; 20...
Beverages·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) Gracie's Kitchen brand Diced Carrots; UPC: 85316-10019; 10 oz plastic container
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Mango; UPC: 85316-10377; 12 oz plastic container b.) King Kullen brand Mango Spears; UPC: 85316-10387; 16 oz plasti...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Tri Colored Noodles; UPC: 85316-10146; 14 oz plastic container
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Stuffed Artichokes; UPC: 85316-10061; 16 oz foam tray b.) Gracie's Kitchen brand Stuffed Artichokes; UPC: 85316-100...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) Wild by Nature brand Sliced Mixed Peppers; UPC: 85316-10102; 12 oz plastic container b.) Gracie's Kitchen brand Sliced Mixed Peppers;...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) WIld by Nature brand Squash Noodles; UPC: 85316-10022; 14 oz plastic container
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) Wild by Nature brand Fruit Spears; UPC: 85316-10393; 24 oz plastic container b.) Gracie's Kitchen brand Fruit Spears; UPC: 85316-1039...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Fajita Mix; UPC: 85316-11090; 12 oz plastic container b.) Gracie's Kitchen brand Fajita Mix; UPC: 85316-10002; 12 o...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Brussel Sprout Halves; UPC: 85316-10097; 12 oz plastic container b.) King Kullen brand Brussel Sprouts Shredded; UP...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Mango Berry; UPC: 85316-10378; 12 oz plastic container b.) Wild By Nature brand Mango Berry; UPC: 85316-10378; 12 o...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Diced White Onion; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced White Onion; UPC: 85316...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Large Fruit Platter; UPC: 85316-10402; 56 oz plastic container b.) Gracie's Kitchen brand Large Fruit Platter; UPC:...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Papaya Chunks; UPC: 85316-10411; 12 oz plastic container
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Fruit Tray; UPC: 85316-10398; 42 oz plastic container b.) King Kullen brand Fruit Tray; UPC: 85316-10399; 1.65 plas...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Pineapple Slices; UPC 85316-10007; 20 oz foam tray b) Wild By Nature brand Pineapple Slices; UPC: 85316-10007; 20 o...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container b.) Wild by Nature brand Peppers & Onions; UPC: 85316-1...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container b.) King Kullen brand Mixed Fruit; UPC: 85316-10385; 16 oz p...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Diced Celery; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced Celery; UPC: 85316-10083; 12...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Halo Bowl; UPC: 85316-10390; 28 oz plastic container b.) Wild by Nature brand Halo Bowl; UPC: 85316-10390; 28 oz pl...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Honeydew Slices; UPC 85316-10009; 20 oz foam tray b) Wild By Nature brand Honeydew Slices; UPC: 85316-10009; 20 oz ...
Food·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) Gracie's Kitchen brand Mango & Blueberry Cup; UPC: 85316-10347; 12 oz plastic container
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Gracie's Kitchens Inc.
a.) King Kullen brand Vegetable Platter; UPC 85316-10005; 44oz plastic container b.) Wild by Nature brand Vegetable Platter; UPC 85316-10...
Produce·3,681 affected·Nov 27, 2024
High RiskFDA
Avkare
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Oral Drugs·2,396 affected·Nov 27, 2024
High RiskFDA
Avkare
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Oral Drugs·2,796 affected·Nov 27, 2024
High RiskFDA
Avkare
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Oral Drugs·50,304 affected·Nov 27, 2024
High RiskFDA
3b Medical, Inc.
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Pro...
Respiratory Devices·5,010 affected·Nov 27, 2024
High RiskFDA
Isotis Orthobiologics, Inc.
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Medical Devices·22 affected·Nov 27, 2024