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High RiskFDA
Atrium Medical Corporation
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Medical Devices·48,339 affected·Sep 18, 2023
High RiskFDA
Nova Biomedical Corporation
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasm...
Medical Devices·161 affected·Sep 18, 2023
High RiskFDA
Atrium Medical Corporation
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, O...
Medical Devices·31,270 affected·Sep 18, 2023
High RiskFDA
Nova Biomedical Corporation
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1...
Medical Devices·1,779 affected·Sep 18, 2023
High RiskFDA
Atrium Medical Corporation
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-10...
Medical Devices·471,037 affected·Sep 18, 2023
CriticalFDA
Tama Corporation
PAISA Sweet Corn Pancakes, Cachapas de Maiz, NET WT. 24 Oz., 5 units, KEEP REFRIGERATED
Bakery & Grains·8,230 affected·Sep 15, 2023
High RiskFDA
Safeway Fresh Foods Llc
Sunnyside Farms, diced Organic Butternut Squash , 32-oz. , plastic tray, 6 trays per case, Perishable Keep Refrigerated .
Dairy·240 affected·Sep 15, 2023
CriticalFDA
Asensus Surgical Inc
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catal...
Surgical Devices·21 affected·Sep 15, 2023
CriticalFDA
Carefusion 303, Inc.
Alaris PCA Module 8120
Medical Devices·86,393 affected·Sep 15, 2023
CriticalFDA
Carefusion 303, Inc.
BD Alaris Syringe Module, REF 8110
Medical Devices·133,727 affected·Sep 15, 2023
High RiskFDA
Tornier, Inc
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Medical Devices·30 affected·Sep 15, 2023
High RiskFDA
Katies Korner Inc.
3 Gallon, plastic container of mint chip flavored ice cream
Dairy·35 affected·Sep 14, 2023
High RiskFDA
Cannihelp Hemp Co Llc Dba The Crooked Row
The Crooked Row - Nkratable 4.5g per bite - 3 bites per pack
Food·261 affected·Sep 14, 2023
High RiskFDA
Ge Healthcare
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Medical Devices·17 affected·Sep 14, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitor...
Medical Devices·45 affected·Sep 14, 2023
High RiskFDA
Ge Healthcare
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Medical Devices·329 affected·Sep 14, 2023
High RiskFDA
Fairfield Gourmet Food Corp D/b/a David's Cookies
Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g), plastic package (i.e.) Clamp shell, 8 package per case, Frozen master case (...
Dairy·120 affected·Sep 13, 2023
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incisio...
Cardiac Devices·2,951 affected·Sep 13, 2023
CriticalFDA
Resmed Ltd.
Astral 100 and Astral 150 ventilators
Respiratory Devices·55,279 affected·Sep 13, 2023
High RiskFDA
Cardinal Health 200, Llc
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Medical Devices·3 affected·Sep 13, 2023
High RiskFDA
Stryker Corporation
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Need...
Medical Devices·19 affected·Sep 13, 2023
CriticalFDA
Knickerbocker 365 Inc.
Knickerbocker Homestyle hamburger buns, 16oz, 8 count in clear plastic bag, UPC 6 11625 10020 6
Food·668 affected·Sep 12, 2023
CriticalFDA
The Kitchen Garden Co, Llc
Fine Sconehenge Baking Company, Lemon Raspberry Scone, individually sealed plastic bag
Produce·0 affected·Sep 12, 2023
CriticalFDA
The Kitchen Garden Co, Llc
Fine Sconehenge Baking Company, CRANBERRY ORANGE SCONE, individually sealed plastic bag
Produce·0 affected·Sep 12, 2023
CriticalFDA
The Kitchen Garden Co, Llc
Fine Sconehenge Baking Company, Chocolate Chip Scone, individually sealed plastic bag
Snacks & Candy·9 affected·Sep 12, 2023
CriticalFDA
The Kitchen Garden Co, Llc
Fine Sconehenge Baking Company, ENGLISH SCONE, individually sealed plastic bag
Food·0 affected·Sep 12, 2023
RecallFDA
Tolmar, Inc.
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935...
Injectable Drugs·2,990 affected·Sep 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides com...
Surgical Devices·12 affected·Sep 12, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per car...
Medical Devices·342 affected·Sep 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Surgical Devices·237 affected·Sep 12, 2023
High RiskFDA
Olympus Corporation Of The Americas
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) ...
Medical Devices·2,496 affected·Sep 12, 2023
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Diagnostic Devices·36 affected·Sep 12, 2023
High RiskFDA
Raysearch Laboratories Ab
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical i...
Medical Devices·2 affected·Sep 12, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Apple Kale flavor; 5 pk and 7 pk; ambient storage
Food·152,655 affected·Sep 11, 2023
High RiskFDA
The Little Oak Company Ltd
LittleOak Natural Goat Milk Follow On Infant Formula (Stage 2); packaged in 800g (1.8lbs) tin cans - six cans per case.
Dairy·15,600 affected·Sep 11, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Strawberry Beet flavor; 5 pk and 7 pk; ambient storage
Produce·152,655 affected·Sep 11, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Blueberry Banana flavor; 5 pk; ambient storage
Produce·152,655 affected·Sep 11, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Carrot Date flavor; 5 pk; ambient storage
Food·152,655 affected·Sep 11, 2023
High RiskFDA
The Little Oak Company Ltd
LittleOak Natural Goat Milk Infant Formula (Stage 1); packaged in 800g (1.8lbs) tin cans - six cans per case.
Dairy·14,100 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Roi Cps Llc
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Medical Devices·103 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Surgical Devices·2,321 affected·Sep 11, 2023
CriticalFDA
Eitan Medical Ltd
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Medical Devices·1,383 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Surgical Devices·2,321 affected·Sep 11, 2023