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High RiskFDA
Avid Medical, Inc.
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
Medical Devices·62 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissu...
Surgical Devices·3,494 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
Cardiac Devices·6 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
Medical Devices·216 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of t...
Surgical Devices·80,515 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
Medical Devices·22 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Medical Devices·36 affected·Sep 20, 2024
High RiskFDA
Avid Medical, Inc.
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Medical Devices·100 affected·Sep 20, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Medical Devices·0 affected·Sep 19, 2024
High RiskFDA
Covidien Lp
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm...
Surgical Devices·16,336 affected·Sep 19, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Medical Devices·542 affected·Sep 19, 2024
High RiskFDA
Ad-tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Medical Devices·14 affected·Sep 19, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
Medical Devices·24 affected·Sep 19, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
Medical Devices·4 affected·Sep 19, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Operating Table TruSystem 7000, Product code REF 1841046
Medical Devices·397 affected·Sep 19, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
Medical Devices·1,077 affected·Sep 19, 2024
High RiskFDA
Enviroserve Chemicals Inc.
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Ave...
Topical Drugs·120 affected·Sep 18, 2024
High RiskFDA
Nihon Kohden America Inc
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Medical Devices·64 affected·Sep 18, 2024
High RiskFDA
American Surgical Company, Llc
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S...
Medical Devices·390 affected·Sep 18, 2024
High RiskFDA
Nihon Kohden America Inc
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Medical Devices·67 affected·Sep 18, 2024
High RiskFDA
Polymer Technology Systems, Inc. Dba Pts Diagnostics, Inc.
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing...
Diagnostic Devices·2,452 affected·Sep 18, 2024
High RiskFDA
Baxter Healthcare Corporation
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900...
Surgical Devices·2,967 affected·Sep 18, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 So...
Surgical Devices·1,749 affected·Sep 18, 2024
High RiskFDA
Topcon Medical Systems, Inc.
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digita...
Diagnostic Devices·3,144 affected·Sep 17, 2024
High RiskFDA
Zimmer, Inc.
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesti...
Medical Devices·432 affected·Sep 17, 2024
High RiskFDA
Datascope Corp.
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Medical Devices·160 affected·Sep 17, 2024
High RiskFDA
Microsurgical Technology Inc
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Mod...
Surgical Devices·24 affected·Sep 17, 2024
High RiskFDA
Canon Medical System, Usa, Inc.
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission To...
Diagnostic Devices·27 affected·Sep 17, 2024
High RiskFDA
Today's Frozen Desserts, Inc.
Premium Grapenut Special, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Frozen Food·1,363 affected·Sep 16, 2024
High RiskFDA
Today's Frozen Desserts, Inc.
Premium Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Frozen Food·1,363 affected·Sep 16, 2024
High RiskFDA
Today's Frozen Desserts, Inc.
Premium Pistachio Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Frozen Food·1,363 affected·Sep 16, 2024
High RiskFDA
Today's Frozen Desserts, Inc.
Rum Nut Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Dairy·1,363 affected·Sep 16, 2024
High RiskFDA
Today's Frozen Desserts, Inc.
Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Dairy·1,363 affected·Sep 16, 2024
High RiskFDA
Abbvie Inc.
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, ...
Topical Drugs·2,473,563 affected·Sep 16, 2024
High RiskFDA
Abbvie Inc.
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Alle...
Topical Drugs·763,426 affected·Sep 16, 2024
High RiskFDA
Cook Incorporated
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to per...
Medical Devices·50 affected·Sep 16, 2024
High RiskFDA
Ambu Inc.
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 41239...
Medical Devices·1,824 affected·Sep 16, 2024
High RiskFDA
Spineology, Inc.
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access...
Medical Implants·190 affected·Sep 16, 2024
High RiskFDA
Imacor Inc.
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Numbe...
Diagnostic Devices·73 affected·Sep 16, 2024
High RiskFDA
Mac & Co
Mini Raspberry Lemon Coffee Cake, net wt. 13.5oz. UPC 8 57297 00745 4. Made with Gluten-Free Ingredients in a Gluten-Friendly Bakery. M...
Dairy·38 affected·Sep 14, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: O...
Medical Devices·738 affected·Sep 13, 2024
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of t...
Medical Devices·209 affected·Sep 13, 2024
High RiskFDA
Integra Lifesciences Corp.
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (M...
Medical Devices·120,124 affected·Sep 13, 2024
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Medical Devices·13,318 affected·Sep 12, 2024
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Medical Devices·15,068 affected·Sep 12, 2024
High RiskFDA
Lemonland Food Corp
Item FLD1040A, Wild Leeks, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Wild Leeks, Sugar, S...
Food·3 affected·Sep 11, 2024
High RiskFDA
Lemonland Food Corp
Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares ...
Food·20 affected·Sep 11, 2024
High RiskFDA
Lemonland Food Corp
Item FLD1015A, Stewed Lotus Root, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Lotus Root, S...
Food·25 affected·Sep 11, 2024