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High RiskFDA
Philips Medical Systems Nederland B.v.
Enterprise 1.5T, Model Number: 781145;
Medical Devices·34 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a v...
Medical Devices·435 affected·Mar 24, 2025
High RiskFDA
Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Cera...
Medical Implants·215 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Omni/Stellar, Model Number: 781104;
Medical Devices·26 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 0.5T Standard, Model Number: 781101;
Medical Devices·14 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 3.0T Quasar Dual, Model Number: 781150;
Medical Devices·12 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Power/Pulsar, Model Number: 781105;
Medical Devices·121 affected·Mar 24, 2025
High RiskFDA
Barry Callebaut Usa Llc
CACAO BARRY Gianduja Noir, 5.5lbs (2.5kg) plastic bucket, 8 buckets per case.
Food·180 affected·Mar 22, 2025
High RiskFDA
Bioriginal Food & Science Corporation
Fresh Flax Oil OMEGA 3-6-9 Organic Flaxseed Oil 16 Fl oz / 473 ml, Dietary Supplement, Black HDPE plastic bottle with cap, Manufactured f...
Supplements·61 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, M...
Injectable Drugs·4,956 affected·Mar 21, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals...
Oral Drugs·13,128 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So...
Injectable Drugs·506,080 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 088...
Injectable Drugs·240 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873,...
Injectable Drugs·997 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India,...
Injectable Drugs·23,960 affected·Mar 21, 2025
High RiskFDA
Ge Medical Systems, Llc
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional ...
Surgical Devices·3,472 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part #...
Medical Devices·40,166 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B...
Medical Devices·70,627 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets w...
Medical Devices·385,920 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Co...
Medical Devices·76,407 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; ...
Medical Devices·34,187 affected·Mar 21, 2025
High RiskFDA
Phasor Health, Llc
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Medical Devices·1,064 affected·Mar 21, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coul...
Diagnostic Devices·0 affected·Mar 20, 2025
High RiskFDA
Abbott Molecular, Inc.
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N...
Medical Devices·0 affected·Mar 20, 2025
High RiskFDA
Maquet Cardiovascular, Llc
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. Th...
Medical Devices·22,244 affected·Mar 20, 2025
High RiskFDA
The Coastal Companies Dba Hearn Kirkwood
Turkey BLT on Sourdough Net Wt. 8.94 OZ (253g) in plastic clamshell
Meat & Poultry·39 affected·Mar 19, 2025
High RiskFDA
Harvey Investments Llc / The Baking Group
Brioche Bread Loaf and Hamburger buns packaged in brown box and labeled as follows: 1. Ben E. Keith Co. Dense Brioche Pullman Loaf, 33...
Bakery & Grains·733 affected·Mar 19, 2025
High RiskFDA
Dessert Holdings Llc
favorite day gourmet New York-Style CHEESECAKE 2 SLICES NET WT 6OZ (170 g) UPC 0 85239 09690 1 Target Brands, Inc.
Dairy·1,117 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Medical Devices·30 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL...
Medical Devices·822 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Medical Devices·2,519,991 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Sterile Water, USP, 100mL, REF RDI30295
Medical Devices·963,054 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Medical Devices·2,220 affected·Mar 19, 2025
High RiskFDA
Spectrum Medical Ltd.
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product ...
Medical Devices·156 affected·Mar 19, 2025
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sens...
Medical Devices·264,252 affected·Mar 19, 2025
High RiskFDA
Delicias De La Abuela Inc
Arepas de Chocolo, Abuelas Food Company, Delicias de la Abuela's, Net Weight: 22.5oz. (638g), 5 units per package, Vacuum seal packages a...
Food·1,504 affected·Mar 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product ...
Medical Devices·2,947 affected·Mar 18, 2025
High RiskFDA
Defibtech, Llc
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (F...
Cardiac Devices·43 affected·Mar 18, 2025
High RiskFDA
Smith & Nephew, Inc.
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Medical Devices·75 affected·Mar 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product ...
Medical Devices·19 affected·Mar 18, 2025
High RiskFDA
Defibtech, Llc
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/E...
Cardiac Devices·13 affected·Mar 18, 2025
High RiskFDA
Defibtech, Llc
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Cardiac Devices·1 affected·Mar 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product ...
Medical Devices·1 affected·Mar 18, 2025
High RiskFDA
Nestle-usa, Inc. (corporate Office)
Lean Cuisine Lemon Garlic Shrimp Stir Fry, NET WT 10 OZ (283g), in a plastic tray with film seal, packaged inside a paperboard carton; 10...
Seafood·7,212 affected·Mar 17, 2025
High RiskFDA
Nestle-usa, Inc. (corporate Office)
Lean Cuisine Spinach Artichoke Ravioli, NET WT 9 OZ (255g), in a plastic tray with film seal, packaged inside a paperboard carton; packed...
Produce·25,485 affected·Mar 17, 2025
High RiskFDA
Pacific Meridian Group, Llc
GOLD GARLIC POWDER IRRADIATED; NET WT. 50 LBS; PRODUCT OF CHINA
Food·175,000 affected·Mar 17, 2025
High RiskFDA
Victor Packing Inc.
Dried Cranberries (21.75 lb/case; 300 - 1.16 oz packages/case)
Produce·34,500 affected·Mar 17, 2025
High RiskFDA
Biocon Pharma Inc
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manu...
Oral Drugs·2,184 affected·Mar 17, 2025