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High RiskFDA
Baxter Healthcare Corporation
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Medical Devices·165 affected·Mar 15, 2024
High RiskFDA
Covidien Lp
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve an...
Surgical Devices·305 affected·Mar 15, 2024
High RiskFDA
Spineart Sa
PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S...
Medical Devices·242 affected·Mar 15, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Medical Devices·18 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Steril...
Surgical Devices·12,588 affected·Mar 14, 2024
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve i...
Medical Devices·3,428 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reor...
Surgical Devices·7,673 affected·Mar 14, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Medical Devices·27 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DY...
Surgical Devices·12,588 affected·Mar 14, 2024
High RiskFDA
Allergan Sales, Llc
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Medical Devices·10,837 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O....
Surgical Devices·7,673 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kel...
Cardiac Devices·7,673 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component M...
Cardiac Devices·12,588 affected·Mar 14, 2024
High RiskFDA
Biomet, Inc.
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with prot...
Medical Devices·19 affected·Mar 13, 2024
High RiskFDA
Electro Medical Systems Sa
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bot...
Medical Devices·462 affected·Mar 13, 2024
High RiskFDA
Electro Medical Systems Sa
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These b...
Medical Devices·54 affected·Mar 13, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using ...
Medical Devices·8,721 affected·Mar 13, 2024
High RiskFDA
Spices Usa Inc.
Tasty-Sawa Cinnamon Ground, Net Wt. 55.11 lbs, paper bag (bulk), Country of Origin Vietnam
Food·394 affected·Mar 12, 2024
High RiskFDA
Eli Lilly & Company
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-...
Injectable Drugs·700 affected·Mar 12, 2024
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ...
Drugs·22,644 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Ingenia 1.5T S, Magnetic Resonance System.
Medical Devices·135 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T, Magnetic Resonance System.
Medical Devices·1,921 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Medical Devices·22 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 3.0T, Magnetic Resonance System.
Medical Devices·511 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
GYROSCAN T5-NT, Magnetic Resonance System.
Medical Devices·23 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T, Magnetic Resonance System.
Medical Devices·347 affected·Mar 12, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Namic FLUID DELIVERY SET, REF 91300040
Medical Devices·50 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Medical Devices·46 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
Medical Devices·2 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.0T Omni/Stellar, Magnetic Resonance System.
Medical Devices·27 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
GYROSCAN ACS-NT, Magnetic Resonance System.
Medical Devices·50 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva XR, Magnetic Resonance System.
Medical Devices·49 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
Medical Devices·20 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Ingenia 1.5T CX, Magnetic Resonance System.
Medical Devices·143 affected·Mar 12, 2024
High RiskFDA
Medline Industries, Lp - Northfield
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; ...
Cardiac Devices·570 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Ingenia Elition S, Magnetic Resonance System.
Medical Devices·131 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
Medical Devices·12 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Ingenia Elition X, Magnetic Resonance System.
Medical Devices·448 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Enterprise 1.5T, Magnetic Resonance System.
Medical Devices·33 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
MR 7700, Magnetic Resonance System.
Medical Devices·26 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
GYROSCAN T5, Magnetic Resonance System.
Medical Devices·7 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Medical Devices·24 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 3.0TX for PET, Magnetic Resonance System.
Medical Devices·1 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera CV, Magnetic Resonance System.
Medical Devices·8 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T Conversion, Magnetic Resonance System.
Medical Devices·115 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T R11, Magnetic Resonance System.
Medical Devices·25 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T Initial, Magnetic Resonance System.
Medical Devices·69 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Medical Devices·19 affected·Mar 12, 2024