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High RiskFDA
Ethicon, Inc.
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic sur...
Medical Devices·341,532 affected·May 10, 2024
CriticalFDA
Canon Medical System, Usa, Inc.
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T ...
Medical Devices·153 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue,...
Medical Devices·56,952 affected·May 10, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumo...
Medical Devices·2 affected·May 10, 2024
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, ...
Surgical Devices·6 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for o...
Medical Devices·55,296 affected·May 10, 2024
High RiskFDA
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
Medical Devices·1,300 affected·May 10, 2024
High RiskFDA
New Classic Cooking Llc
Veggies Made Great brand Broccoli Cheddar Breakfast Potato Bakes. Net Wt. 36 OZ (2.25 LB) 1.02 KG. UPC: 70486300103. Frozen product. Indi...
Frozen Food·10,544 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SO...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Stryker Gmbh
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Medical Devices·39 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle asid...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
First Source Inc
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Medical Devices·680 affected·May 9, 2024
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Cardiac Devices·1,745 affected·May 9, 2024
High RiskFDA
Echonous Inc
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Diagnostic Devices·272 affected·May 9, 2024
High RiskFDA
Della Fattoria, Llc
Della Fattoria Seeded Wheat
Food·115 affected·May 8, 2024
CriticalFDA
Bonbon Nyc Llc.
Marabou Sea Salt Chocolate Bar; 185g; yellow plastic packaging and the word 'havvsalt', the Swedish word for "sea salt"; product is a fla...
Snacks & Candy·3 affected·May 8, 2024
High RiskFDA
Texas Pecan Co
1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, ...
Produce·71,048 affected·May 8, 2024
High RiskFDA
Foodscience, Llc
Amyloid Complete
Food·72 affected·May 8, 2024
High RiskFDA
Texas Pecan Co
1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, ...
Produce·71,048 affected·May 8, 2024
High RiskFDA
Della Fattoria, Llc
Della Fattoria Sicilian Semolina
Food·115 affected·May 8, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltim...
Oral Drugs·51,006 affected·May 8, 2024
High RiskFDA
Baxter Healthcare Corporation
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or tre...
Medical Devices·38,136 affected·May 8, 2024
High RiskFDA
Macleods Pharma Usa, Inc
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA,...
Oral Drugs·1,048 affected·May 7, 2024
High RiskFDA
Pacira Pharmaceuticals Inc
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: P...
Injectable Drugs·43,768 affected·May 7, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15...
Medical Devices·2,860 affected·May 7, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or...
Medical Devices·3,618 affected·May 7, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lo...
Medical Devices·230 affected·May 7, 2024
CriticalFDA
Icu Medical Inc
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, ...
Medical Devices·14,744 affected·May 7, 2024
High RiskFDA
Blue Belt Technologies, Inc
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spati...
Medical Devices·916 affected·May 7, 2024
CriticalFDA
Western Mixers Produce & Nuts, I
Smart & Final, First Street Brand Yogurt Pretzels; plastic containers, 6 oz & 15 oz. Product Lot #: 241091, 241161, 241241 Gelson s, Gel...
Dairy·42 affected·May 6, 2024
High RiskFDA
Gns Foods, Inc
Drug Emporium Yogurt Flavored Pretzels, 8oz (227g) , GNS Foods, Arlington, TX 76011
Dairy·96 affected·May 6, 2024
High RiskFDA
Rubicon Research Private Limited
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubi...
Oral Drugs·11,664 affected·May 6, 2024
High RiskFDA
Novasignal Corp.
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Medical Devices·28 affected·May 6, 2024
High RiskFDA
Novasignal Corp.
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Medical Devices·45 affected·May 6, 2024
High RiskFDA
American Contract Systems, Inc.
American Contract Systems Spine Pack convenience kit
Medical Devices·3 affected·May 6, 2024
High RiskFDA
American Contract Systems, Inc.
American Contract Systems Hand Pack convenience kit
Medical Devices·90 affected·May 6, 2024
High RiskFDA
American Contract Systems, Inc.
American Contract Systems Biopsy Drape Pack convenience kit
Medical Devices·224 affected·May 6, 2024
CriticalFDA
Palmer & Company
1. Palmer Candy Drizzled Caramel Corn, Item 19271, Net Wt. 16/5oz tubs, UPC 77343 19271 2. Meijer Drizzled Caramel Popcorn Snack Bowl, Ne...
Snacks & Candy·0 affected·May 3, 2024
CriticalFDA
Danisco Usa Inc.
Grindsted Sweetlife CINN. Roll BAS Stabilizer & Emulsifier System, 22.68 kg/ 50 lb bag
Food·7,257 affected·May 3, 2024
CriticalFDA
Palmer & Company
Palmer Patriotic Munchy Medley, Net Wt 15oz, UPC 7723237060, 12/15oz case
Food·0 affected·May 3, 2024
High RiskFDA
Clasen Quality Chocolate Inc.
Milk Chocolate Flavored Confectionery Coating Bulk (MB), Item # 60692.
Dairy·87,045 affected·May 3, 2024
CriticalFDA
Danisco Usa Inc.
Grindsted Hi-Dress CDS 1880 Stabilizer and Emulsifier System, 22.68 kg / 50 lb bag
Food·7,030 affected·May 3, 2024
CriticalFDA
Danisco Usa Inc.
Grindsted SSD 5731 Non-GMO Stabilizer System, 22.68 kg / 50 lb bag
Food·3,628 affected·May 3, 2024
CriticalFDA
Danisco Usa Inc.
Grindsted Creamer 2103 Stabilizer and Emulsifier System, 22. 68 kg / 50 lb bag
Food·36,265 affected·May 3, 2024
CriticalFDA
Palmer & Company
1. Freshness Guaranteed Peanut Butter Snack Mix, Net Wt 12oz, UPC 78742 03912, 8/12oz case 2. Peanut Butter Snack Mix, Net Wt 4.5oz to go...
Dairy·0 affected·May 3, 2024
High RiskFDA
Grato Holdings, Inc.
Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle.
Supplements·1,912 affected·May 3, 2024