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High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (li...
Diagnostic Devices·8,420 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithi...
Diagnostic Devices·13,071 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithiu...
Diagnostic Devices·5,315 affected·Jan 27, 2023
High RiskFDA
Coopervision, Inc.
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Medical Devices·24 affected·Jan 26, 2023
High RiskFDA
Coopervision, Inc.
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Diagnostic Devices·4 affected·Jan 26, 2023
High RiskFDA
Joy Joys Bakery Llc
Ube Spanish Bread, UPC 36897113. Product is packaged in plastic clear clamshell container and there are 6 pieces per container. Ingredie...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
Vietnamese Coffee Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37080 7.
Dairy·21 affected·Jan 25, 2023
High RiskFDA
Joy Joys Bakery Llc
Ube Ensaymada, UPC 6658266481. Product is packaged in plastic clear clamshell container and there are 4 pieces per container. Ingredients...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
Coconut Pandan Cheesecake Coconut Butter Biscuit Crust (4oz) - 6 60845 37071 5.
Dairy·23 affected·Jan 25, 2023
High RiskFDA
Alpenland International, Inc.
HEILEMANN CONFISERIE WEHNACHTSFIGUREN AUS EDELVOLLMILCH-SCHOKOLADE Solid Chocolate Holiday Treats 3.5 oz box UPC 4006574007199
Snacks & Candy·220 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
Ube (Purple Yam) Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37067 8. Ube (Purple Yam) Cheesecake Coconut Butter Biscuit...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Joy Joys Bakery Llc
Ube Roll UPC 35961092. Product is packaged in plastic clear clamshell container and there are 3 pieces per container. Ingredients: Ube F...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
White Chocolate Guava Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37077 7.
Dairy·35 affected·Jan 25, 2023
High RiskFDA
Church & Dwight Inc
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text ...
Medical Devices·780,000 affected·Jan 25, 2023
High RiskFDA
Limacorporate S.p.a
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Medical Devices·5 affected·Jan 25, 2023
CriticalFDA
Baxter Healthcare Corporation
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Respiratory Devices·8 affected·Jan 25, 2023
High RiskFDA
Stryker Corporation
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Medical Devices·88 affected·Jan 25, 2023
CriticalFDA
Covidien, Lp
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Medical Devices·264 affected·Jan 25, 2023
High RiskFDA
Stryker Corporation
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimati...
Medical Devices·541 affected·Jan 25, 2023
High RiskFDA
Bake'n Joy Foods, Inc.
Gordon Choice Cranberry Orange Flavored Nut muffin batter; 8lbs; packaged in pails
Produce·436 affected·Jan 24, 2023
High RiskFDA
Carefusion 303, Inc.
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Medical Devices·83,185 affected·Jan 24, 2023
High RiskFDA
Intuitive Surgical, Inc.
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, ...
Surgical Devices·9 affected·Jan 24, 2023
CriticalFDA
Draeger Medical, Inc.
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Medical Devices·893 affected·Jan 23, 2023
CriticalFDA
Draeger Medical, Inc.
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Medical Devices·16 affected·Jan 23, 2023
RecallFDA
Snack Innovations Inc.
Drizzilicious Mini Rice Cake bites Net Wt. 4oz and/or .74oz Bags Salted Caramel UPC:857900005167 and 857900005181 Packaged in a plastic ...
Bakery & Grains·3,224 affected·Jan 20, 2023
RecallFDA
Snack Innovations Inc.
Drizzilicious Mini Rice Cake bites Net Wt. 4oz and/or .74oz Bags Cookies & Cream UPC: 857900005167 and 857900005181 Packaged in a plast...
Dairy·1,844 affected·Jan 20, 2023
High RiskFDA
United States Bakery Dba Franz Bakery
Kirkland Signature 18 Sandwich Rolls Ideal for Hot Dogs, net wt. 54 oz. UPC 0 96619 49013 4. Product is ambient does not require special ...
Food·66 affected·Jan 20, 2023
RecallFDA
Snack Innovations Inc.
Safe & fair 7.5 oz drizzled popcorn Honey Crisp Apple Pie Packaged in a plastic bags
Snacks & Candy·2,528 affected·Jan 20, 2023
RecallFDA
Snack Innovations Inc.
Drizzilicious drizzled Birthday Cake Popcorn 3.6oz Bags UPC: 857900005525 Packaged in a plastic bags
Bakery & Grains·1,117 affected·Jan 20, 2023
RecallFDA
Snack Innovations Inc.
Drizzilicious Mini Rice Cake bites Net Wt. 4oz and .74oz Bags Birthday Cake UPC: 857900005402 and 857900005419 Packaged in a plastic bag...
Bakery & Grains·6,701 affected·Jan 20, 2023
RecallFDA
Snack Innovations Inc.
The Safe + Fair Food Company Key Lime Pie Drizzled Popcorn Kettle Popped Net Wt. 7.5 oz (212g) Packaged in a plastic bags
Snacks & Candy·1,267 affected·Jan 20, 2023
RecallFDA
Snack Innovations Inc.
Drizzilicious Mini Rice Cake bites Net Wt.4oz and or .74oz Bags Cinnamon Swirl UPC: 857900005167 and UPC:857900005181 Packaged in a plas...
Bakery & Grains·10,429 affected·Jan 20, 2023
RecallFDA
Lupin Pharmaceuticals Inc.
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manu...
Topical Drugs·5,720 affected·Jan 20, 2023
RecallFDA
Surepulse Medical Ltd
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Cardiac Devices·0 affected·Jan 20, 2023
RecallFDA
Surepulse Medical Ltd
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Cardiac Devices·0 affected·Jan 20, 2023
High RiskFDA
Medtronic Neuromodulation
SenSight Connector Plug, Model Number B31061.
Medical Devices·65 affected·Jan 20, 2023
High RiskFDA
Coltene Whaledent Inc
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation...
Medical Devices·3,896 affected·Jan 20, 2023
RecallFDA
Skinny Dipped
Skinny Dipped Dark Chocolate Cocoa Almonds, 3.5 oz, packaged in flexible plastic pouches inside cardboard cases. Ingredients: Almonds, Da...
Dairy·1,134 affected·Jan 19, 2023
RecallFDA
Clasen Quality Chocolater, Inc
4M DF NSA Semisweet Baking Drop (FT), Item # 56854. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Chocolate Liquor, Inulin...
Dairy·19,120 affected·Jan 18, 2023
RecallFDA
Clasen Quality Chocolater, Inc
Milk Choc Flvd Confectionery Wafer (HP, NSA), Item # 52546. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Palm Kernal Oil,...
Dairy·0 affected·Jan 18, 2023
Medium RiskFDA
Clasen Quality Chocolater, Inc
2M Semisweet Chocolate Drop, Item # 53700. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Unsweetened Chocolate, Sugar, Coc...
Dairy·150,600 affected·Jan 18, 2023
RecallFDA
Clasen Quality Chocolater, Inc
4M Milk Chocolate Drop, Item # 57667. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Whole Milk, Chocolate Liquor, C...
Dairy·29,000 affected·Jan 18, 2023
RecallFDA
Clasen Quality Chocolater, Inc
4M Cinnamon Flvd Confectionery Drop (MB), Item # 56466. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel O...
Dairy·90,450 affected·Jan 18, 2023
RecallFDA
Clasen Quality Chocolater, Inc
DF Dark Choc Flvd Wafer (MB), Item # 56810. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Cocoa Po...
Snacks & Candy·32,800 affected·Jan 18, 2023
RecallFDA
Clasen Quality Chocolater, Inc
DF 85% Cacao Bittersweet Chocolate Wafer, Item # 54213. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Chocolate, Sugar, Su...
Snacks & Candy·40,000 affected·Jan 18, 2023
RecallFDA
Clasen Quality Chocolater, Inc
DF ANSA Choc Flvd Conf Wafer (MB), Item # 59154. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Soluble Corn Fiber, Palm Ke...
Snacks & Candy·41,400 affected·Jan 18, 2023
RecallFDA
Clasen Quality Chocolater, Inc
NGMO Ballard Semisweet Chocolate Wafer, Item # 59343. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Chocolate Liquor (Pro...
Dairy·77,850 affected·Jan 18, 2023
Medium RiskFDA
Clasen Quality Chocolater, Inc
DF FT Simple Free Dark Wafer (MB), Item # 12957. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernal Oil, Coc...
Snacks & Candy·213,450 affected·Jan 18, 2023