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High RiskFDA
Stryker Spine
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Medical Implants·56 affected·Feb 28, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Medical Devices·122 affected·Feb 28, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Medical Devices·1 affected·Feb 28, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Medical Devices·1,876 affected·Feb 28, 2025
High RiskFDA
Stryker Spine
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Medical Implants·64 affected·Feb 28, 2025
High RiskFDA
Uncle Rays, Llc
Coyote Valley Sour Cream & Onion Chips, Net Wt. 5oz, UPC 744234810775, Item # 8014265, Food Express USA, Dallas, TX 75261
Dairy·3,005 affected·Feb 27, 2025
High RiskFDA
Amgen, Inc.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solu...
Injectable Drugs·313,620 affected·Feb 27, 2025
High RiskFDA
Amgen, Inc.
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use...
Injectable Drugs·258,750 affected·Feb 27, 2025
High RiskFDA
Beckman Coulter, Inc.
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Diagnostic Devices·10,000 affected·Feb 27, 2025
High RiskFDA
Biofire Diagnostics, Llc
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Medical Devices·29 affected·Feb 27, 2025
High RiskFDA
Premier Dental Products Co
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Medical Devices·77 affected·Feb 27, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . ...
Medical Devices·439 affected·Feb 26, 2025
High RiskFDA
A-s Medication Solutions Llc
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-149...
Oral Drugs·411 affected·Feb 25, 2025
High RiskFDA
Mylan Pharmaceuticals Inc
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 03...
Oral Drugs·0 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and ...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Medical Devices·93 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Medical Devices·40 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional a...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500, Product Code 4091000
Medical Devices·1,709 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Stationary column TruSystem 7500, Product Code 1717020
Medical Devices·462 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Medical Devices·2 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Medical Devices·8 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Medical Devices·0 affected·Feb 25, 2025
High RiskFDA
Denison Pharmaceuticals, Llc
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 80...
Topical Drugs·642,131 affected·Feb 24, 2025
High RiskFDA
Pyrames Inc
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Medical Devices·35 affected·Feb 24, 2025
High RiskFDA
Prep'd Cda Llc
Chocolate Peanut Butter Protein Balls. Product has expected life of 2 weeks and does not require refrigeration. Product is packaged in se...
Dairy·240 affected·Feb 23, 2025
High RiskFDA
Shearer's Foods, Llc
1.) Market Pantry Soup & Oyster Crackers, NET WT 9 OZ (255g), packaged in flexible plastic bags, 12 count per case, Distributed By: Targe...
Seafood·1 affected·Feb 21, 2025
High RiskFDA
Danone Wave
HAZELNUT INTERNATIONAL delight COFFEE CREAMER 32 FL OZ (1 QT) 32 FL OZ (1 QT) 946 mL UPC 0 41271 02565 2 Distributed by: Danone US, LLC
Beverages·4,762 affected·Feb 21, 2025
High RiskFDA
Danone Wave
CINNABON CLASSIC CINNAMON ROLL INTERNATIONAL delight COFFEE CREAMER 32 FL OZ (1 QT) 946 mL UPC 0 41271 01993 3 Distributed by: Danone US,...
Beverages·7,747 affected·Feb 21, 2025
High RiskFDA
Orthofix U.s. Llc
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP...
Medical Implants·20 affected·Feb 20, 2025
High RiskFDA
Microbiologics Inc
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalo...
Diagnostic Devices·6 affected·Feb 20, 2025
High RiskFDA
Microbiologics Inc
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control mat...
Respiratory Devices·28 affected·Feb 20, 2025
High RiskFDA
Omnicell, Inc.
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, ...
Medical Devices·3 affected·Feb 20, 2025
High RiskFDA
Ge Healthcare
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; ...
Medical Devices·4 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular info...
Medical Devices·2 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS ...
Medical Devices·11 affected·Feb 19, 2025