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CriticalFDA
Perfection Bakeries Llc
Aunt Millie s Bakehouse Texas Toast 3/4" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9519. Net. Wt. 16lb...
Food·1,500 affected·Sep 13, 2024
CriticalFDA
Nuts.com
S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016
Food·3,716 affected·Sep 13, 2024
CriticalFDA
Perfection Bakeries Llc
Aunt Millie s Bakehouse 100% Whole Wheat Pullman Bread 1/2" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9...
Bakery & Grains·924 affected·Sep 13, 2024
CriticalFDA
Perfection Bakeries Llc
Aunt Millie s Bakehouse Whole Grain White Hot Dog Buns 6" Sliced 2 OUNCE. 12 unlabeled 12CT PKGS per sale unit case, product code 7502. ...
Food·10,987 affected·Sep 13, 2024
CriticalFDA
Perfection Bakeries Llc
Gordon Food Service Hawaiian Pull-Apart Dinner Rolls Unsliced 1.25 Ounce. 10 unlabeled 12CT PKGS per sale unit case, product code 7148. ...
Food·61,658 affected·Sep 13, 2024
CriticalFDA
Zyno Medical Llc
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.0...
Medical Devices·34,994 affected·Sep 13, 2024
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4...
Respiratory Devices·10,957 affected·Sep 12, 2024
CriticalFDA
Lemonland Food Corp
Item FLD2011, Salted and Seasoned Small Octopus, distributed in plastic clamshell containers, net wt. 0.267lb. The H-Mart label declares...
Produce·70 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD1080A, Seasoned Radish, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Radish, Red Pep...
Food·30 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD1070A, Seasoned Dandelion, distributed in plastic clamshell containers. Net wt. 0.365lb. The H-Mart label declares: Dandelion, S...
Food·10 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD1020A, Seasoned Pepper with Soybean Paste, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declar...
Food·6 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise...
Produce·120 affected·Sep 11, 2024
CriticalFDA
Innovation Bakers, Llc
7-Eleven Fudge Brownie with Chocolate Chip, 3.5 oz. UPC: 05254856392
Snacks & Candy·2,081 affected·Sep 9, 2024
CriticalFDA
Gorilla Mind Llc
Gorilla Mind Rauwolscine Dietary Supplement, Suppress Appetite, Increased Fat Loss, Increased Energy, dosage 3mg, 90 capsules per bottle,...
Supplements·1,348 affected·Sep 6, 2024
CriticalFDA
Eagle Produce Llc, Dba Martori Farms
Whole cantaloupe, brand name Kandy, packed in a corrugated box, 9 count
Food·224 affected·Sep 5, 2024
CriticalFDA
Datex--ohmeda, Inc.
GE Heathcare Giraffe OmniBed; neo natal incubator
Medical Devices·0 affected·Sep 3, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion managemen...
Medical Devices·17 affected·Aug 30, 2024
CriticalFDA
Mercury Enterprises, Inc. Dba Mercury Medical
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Respiratory Devices·1,300 affected·Aug 30, 2024
CriticalFDA
The Posh Bakery, Inc.
Whole Grains Bakery labeled "Raisin Bran Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 0...
Food·160 affected·Aug 27, 2024
CriticalFDA
Sri Lakshmi Narasimhar Overseas
Bliss Tree Millet Butter Murukku 200g UPC:8906087451631. Packaged in box, 13 boxes per cases. Bliss Tree Millet Butter Murukku 400g UPC:8...
Dairy·213 affected·Aug 22, 2024
CriticalFDA
Kinova Inc
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the functi...
Medical Devices·949 affected·Aug 22, 2024
CriticalFDA
Unilever North America Supply Chain Company, Llc
Popsicle Jolly Rancher Frozen Confection Pop Net Wt 2.71 FL OZ (80 ML). Green Apple Blue Raspberry and Grape flavored. GTIN/UPC 100775670...
Produce·146,000 affected·Aug 21, 2024
CriticalFDA
Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Respiratory Devices·2,523 affected·Aug 21, 2024
CriticalFDA
Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Respiratory Devices·50,460 affected·Aug 21, 2024
CriticalFDA
Milo's Poultry Farms, Llc
Grade A Brown Chicken Eggs, in shell, Bulk 15 dozen. For Foodservice. Keep Refrigerated. Sold with the following brands: 1. Milo's P...
Meat & Poultry·108,155 affected·Aug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Medical Devices·2,140,046 affected·Aug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Medical Devices·1,548,782 affected·Aug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Medical Devices·5,828,540 affected·Aug 20, 2024
CriticalFDA
Prime Food Processing Corp.
Prime Food brand Steam Bun with Egg Custard & Coconut Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: ...
Dairy·477 affected·Aug 9, 2024
CriticalFDA
Prime Food Processing Corp.
Prime Food brand Steam Bun with Egg Custard Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached W...
Dairy·477 affected·Aug 9, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Meijer Inc
MEIJER DUNKING COOKIES CHOCOLATE CHIP, 10oz in clear plastic container. UPC 7-13733-71297-2
Bakery & Grains·13,080 affected·Aug 7, 2024
CriticalFDA
Paradise Distributors, Llc
Yummy brand Swirly Ices Fruity Melon flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007536 Als...
Produce·268 affected·Aug 2, 2024
CriticalFDA
Paradise Distributors, Llc
Yummy brand Swirly Ices Berry Blast flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007550 Als...
Produce·262 affected·Aug 2, 2024
CriticalFDA
Paradise Distributors, Llc
Yummy brand Swirly Ices Tropical Tornado flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007567...
Food·275 affected·Aug 2, 2024
CriticalFDA
Paradise Distributors, Llc
Yummy brand Swirly Ices Churning Cherry flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007543 ...
Food·310 affected·Aug 2, 2024
CriticalFDA
Paradise Distributors, Llc
Yummy brand Swirly Ices Assorted Flavors Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007574. Cont...
Produce·282 affected·Aug 2, 2024
CriticalFDA
Thal Golden Spices Inc.
Bikano Moong Dal Crunchy Green Gram Net Weight 12.35oz (350g) Product of India Manufactured by: Bikanervala Foods Pvt. Ltd. B1-Plot No. ...
Food·20 affected·Aug 1, 2024
CriticalFDA
North Fish Usa, Inc.
Cold Smoked Capelin, 9-ounce packages, plastic trays, 34 packages per case (Best By Date:07.13.2024), 18 packages per case (Best Buy Date...
Frozen Food·34 affected·Aug 1, 2024
CriticalFDA
Baxter Healthcare Corporation
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container,...
Injectable Drugs·44,208 affected·Aug 1, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous in...
Medical Devices·180 affected·Aug 1, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Fresh Guacamole Dip, Net Wt 14 oz (396g). UPC 0 72431-66072 6. Keep Refrigerated.
Food·572 affected·Jul 31, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Spicy Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66128 0. Keep Refrigerated.
Food·121 affected·Jul 31, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Deli Guacamole, Item 85999. Net Wt 56 oz. Keep Refrigerated.
Food·28 affected·Jul 31, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Smokin' Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66130 3. Keep Refrigerated.
Food·78 affected·Jul 31, 2024
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MM...
Diabetes Devices·234,360 affected·Jul 31, 2024