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CriticalFDA
Amazon Retail Llc
ASIN B0CY2RDW5T, Amazon Fresh brand, Bake at Home Jumbo Sugar Cookie 30oz, product is frozen dough, and packaged in flexible plastic bag....
Bakery & Grains·192 affected·Jan 25, 2025
CriticalFDA
Amazon Retail Llc
ASIN B084PZ7K98, Amazon Fresh Jumbo Sugar Cookie, 27 oz (12 count), product is baked and packaged in flexible plastic bag. 4-day shelf li...
Bakery & Grains·269 affected·Jan 25, 2025
CriticalFDA
La Fiesta Food Products
La Fiesta PAN RAYADO SAZONADO Bread Crumbs Seasoned, NET WT 8 OZ. (227g), UPC# 032327000887
Bakery & Grains·520 affected·Jan 22, 2025
CriticalFDA
La Fiesta Food Products
La Fiesta PAN RAYADO Bread Crumbs, NET WT 8 OZ. (227g), UPC# 032327000886
Bakery & Grains·2,200 affected·Jan 22, 2025
CriticalFDA
Provepharm Inc.
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Pro...
Injectable Drugs·24,640 affected·Jan 21, 2025
CriticalFDA
Arizona Foods Group, Inc.
FOOD SERVICE - Mombo s Vanilla Soft Serve Ice Cream Mix, frozen & thawed for Ice cream machines. Packaged in a half gallon carton 64 o...
Dairy·4,422 affected·Jan 19, 2025
CriticalFDA
Piu Che Dolci Inc.
Sweet Cream Mini Patisseries, 30 piece variety tray of mini pastries, Net Wt 1 kg, 4 trays per master carton, total Net wt 8.8 lbs, Keep ...
Dairy·1,923 affected·Jan 17, 2025
CriticalFDA
Wismettac Asian Foods, Inc.
Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Curry Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD; Nutri...
Snacks & Candy·5,764 affected·Jan 16, 2025
CriticalFDA
Wismettac Asian Foods, Inc.
Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Sea Salt & Umami Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.M...
Snacks & Candy·4,253 affected·Jan 16, 2025
CriticalFDA
Wismettac Asian Foods, Inc.
Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Corn Potage Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD;...
Snacks & Candy·5,871 affected·Jan 16, 2025
CriticalFDA
Akt Trading Inc.
Menma Ajitsuke prepared bamboo shoots; Product of Japan; Manufactured by: Choshiya Honten CO., LTD. Hamamatsu 431-1103 Japan UPC 4 92367...
Food·1,200 affected·Jan 15, 2025
CriticalFDA
Mutual Trading Company Inc.
Product is individually packaged in opaque airtight plastic packaging with Chinese lettering on one side. Opposite side contains English...
Seafood·70 affected·Jan 15, 2025
CriticalFDA
Olympus Corporation Of The Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2...
Respiratory Devices·454 affected·Jan 15, 2025
CriticalFDA
Getinge Usa Sales Inc
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For...
Medical Devices·6 affected·Jan 15, 2025
CriticalFDA
Frito-lay, Inc. Headquarters
Pearl Milling Company Original Pancake & Waffle Mix 32 OZ (2LB) 907g 30000 65040 BBD SEP 13 25 P
Bakery & Grains·10,000 affected·Jan 14, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Medical Devices·479 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Medical Devices·735 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura CV20; Catalog numbers: 722031
Medical Devices·111 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Medical Devices·4,221 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Medical Devices·263 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Medical Devices·5,029 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Medical Devices·3 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Catalog numbers: 722058
Medical Devices·302 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Medical Devices·282 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Medical Devices·2 affected·Jan 13, 2025
CriticalFDA
Seoul Trading, Inc.
Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea....
Dairy·78 affected·Jan 10, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the co...
Medical Devices·23 affected·Jan 10, 2025
CriticalFDA
Spectranetics Corporation
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm...
Medical Implants·2,939 affected·Jan 10, 2025
CriticalFDA
Apna Wholesale Inc.
Paras Premium Golden Raisins; 7 oz and 14 oz; INGREDIENTS: RAISINS; ALLERGEN STATEMENT: Processed in a gluten-free and peanut-free plant;...
Food·598 affected·Jan 7, 2025
CriticalFDA
The Mochi Ice Cream Company
My Mochi Sorbet Peach Mango Sorbet; Keep Frozen; 6 pieces per container; 6-1.25 OZ (35g) PIECES NET WT 7.5 OZ (210g)*** Nutritional Panel...
Frozen Food·1,350 affected·Jan 6, 2025
CriticalFDA
Middle East/ Soli's Baking Company, Inc. Dba Middle East Baking Co.
CAIRO BAKERY PITA POCKET BREAD TRADITIONAL RECIPE EXTRA LARGE 6 COUNT, NET WT. 16 OZ. (1 lb.) (454g)
Bakery & Grains·48 affected·Jan 3, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Medical Devices·58 affected·Dec 31, 2024
CriticalFDA
Roi Cps Llc
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor ...
Medical Devices·414 affected·Dec 26, 2024
CriticalFDA
Astellas Pharma Us Inc.
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northb...
Oral Drugs·14,340 affected·Dec 23, 2024
CriticalFDA
Astellas Pharma Us Inc.
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma U...
Oral Drugs·3,500 affected·Dec 23, 2024
CriticalFDA
Percussionaire Corporation
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51...
Respiratory Devices·4,727 affected·Dec 23, 2024
CriticalFDA
Endo Usa, Inc.
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceu...
Inhaled / Nasal Drugs·44,397 affected·Dec 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Respiratory Devices·187 affected·Dec 20, 2024
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assis...
Medical Devices·0 affected·Dec 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Respiratory Devices·1 affected·Dec 20, 2024
CriticalFDA
Abbey Specialty Foods
Wicklow Gold Cheddar Tomato & Herb, 5.2 oz., plastic cryo-vac , 8 packages per case
Produce·100 affected·Dec 18, 2024
CriticalFDA
Abbey Specialty Foods
Wicklow Gold Cheddar Nettle & Chive Cheese, 5.2 oz., plastic cryo-vac , 8 packages per case
Dairy·133 affected·Dec 18, 2024
CriticalFDA
Alcon Research Llc
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Ophthalmic Drugs·55,960 affected·Dec 18, 2024
CriticalFDA
Olympus Corporation Of The Americas
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached...
Surgical Devices·30,140 affected·Dec 18, 2024
CriticalFDA
Orgain, Llc
Orgain 30g Plant Protein, Complete Protein Powder, 6g Prebiotic +Fiber, 9g EAAS+BCAAs, 1gSugar, Chocolate Flavor; NET WT 32.1 OZ (2.01 LB...
Snacks & Candy·523 affected·Dec 17, 2024
CriticalFDA
Pinsarella Food Llc
Pinsarella Roman Pizza, POL127-24, UPC 6 08539 14655 0 -Oval, 12x7/ 7.0 Oz, Parbaked, 6 units per bag, 24 units per box., UPC 1 98715 694...
Frozen Food·66 affected·Dec 16, 2024
CriticalFDA
Shoppers- Plaza
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of...
Oral Drugs·172 affected·Dec 16, 2024
CriticalFDA
Medline Industries, Lp - Northfield
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIK...
Medical Devices·3,930 affected·Dec 16, 2024