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High RiskFDA
Zhejiang Jingwei Pharmaceutical Co., Ltd.
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Di...
Topical Drugs·295,164 affected·Sep 11, 2024
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halo...
Injectable Drugs·5 affected·Sep 11, 2024
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Ophthalmic Drugs·27 affected·Sep 11, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Infusion Pump. Product Number: 8637-20
Medical Devices·1 affected·Sep 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 6105...
Medical Devices·14,093 affected·Sep 11, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Medical Devices·32 affected·Sep 11, 2024
High RiskFDA
Coca Cola Consolidated Llc
Minute Maid Zero Sugar Lemonade 12 cans carton UPC 0 25000 12115 9 CANNED UNDER THE AUTHORITY OF THE COCA-COLA COMPANY, ATLANTA, GA
Food·13,152 affected·Sep 10, 2024
High RiskFDA
Avole, Inc.
Bacalaitos Criollos, CODFISH FRYING MIX, 7 oz., packaged in a plastic bag, 24 packages (units) per cases of 7 onz.
Seafood·100 affected·Sep 9, 2024
High RiskFDA
Kent Precision Foods Group, Inc.
1. Sqwincher Electrolyte Beverage Mix, orange powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025004; packaged in assorted cas...
Beverages·1,231 affected·Sep 9, 2024
High RiskFDA
Kent Precision Foods Group, Inc.
Sqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item nu...
Beverages·251 affected·Sep 9, 2024
High RiskFDA
Atrium Medical Corporation
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Medical Implants·11 affected·Sep 9, 2024
High RiskFDA
Hydration Labs Inc. Dba Bevi
Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single u...
Beverages·1,611 affected·Sep 6, 2024
High RiskFDA
Enchroma Inc
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SU...
Medical Devices·53 affected·Sep 6, 2024
High RiskFDA
Agfa Healthcare Nv
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-...
Diagnostic Devices·801 affected·Sep 6, 2024
High RiskFDA
Shimadzu Corporation Medical Systems Division
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including ...
Medical Devices·3 affected·Sep 6, 2024
High RiskFDA
Empower Pharmacy
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empowe...
Injectable Drugs·450 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive dis...
Cardiac Devices·6 affected·Sep 5, 2024
High RiskFDA
Beckman Coulter, Inc.
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobu...
Diagnostic Devices·465,481 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive displ...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Luminex Molecular Diagnostics Inc
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Respiratory Devices·613 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provid...
Cardiac Devices·9 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide p...
Cardiac Devices·161 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display ...
Cardiac Devices·2 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to pro...
Cardiac Devices·58 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive dis...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive displ...
Cardiac Devices·1 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·92 affected·Sep 5, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Surgical Devices·279 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for fre...
Medical Devices·25 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF...
Medical Devices·197 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c)...
Medical Devices·1,048 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX U...
Medical Devices·8,830 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Medical Devices·15 affected·Sep 4, 2024
High RiskFDA
Bard Peripheral Vascular Inc
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refl...
Surgical Devices·222,373 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Medical Devices·165 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT,...
Cardiac Devices·2,631 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
Medical Devices·30 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Medical Devices·160 affected·Sep 4, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Medical Devices·1 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
Medical Devices·144 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CD...
Medical Devices·2,371 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK...
Medical Devices·27,906 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1...
Medical Devices·320 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
Medical Devices·90 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
Medical Devices·90 affected·Sep 4, 2024
High RiskFDA
Howmedica Osteonics Corp.
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and r...
Medical Implants·16 affected·Sep 4, 2024
High RiskFDA
B-k Medical A/s
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery...
Medical Devices·1,648 affected·Sep 4, 2024