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High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of so...
Medical Devices·1,373 affected·Aug 13, 2024
High RiskFDA
Zoe Medical Incorporated
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Medical Devices·1,506 affected·Aug 13, 2024
High RiskFDA
Flagstone Foods, Llc
6.5oz Emerald Kettle Glazed Walnut, UPC: 0 10300 80894 7
Food·0 affected·Aug 12, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx o...
Ophthalmic Drugs·176,784 affected·Aug 12, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, REF: K12T-11077
Medical Devices·24 affected·Aug 12, 2024
High RiskFDA
Smith & Nephew Inc.
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 7...
Medical Implants·2,961 affected·Aug 12, 2024
High RiskFDA
Seer Medical Pty Ltd
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recor...
Medical Devices·3,948 affected·Aug 12, 2024
High RiskFDA
Direct Rx
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, ...
Oral Drugs·1,410 affected·Aug 9, 2024
High RiskFDA
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor Model BSM2050
Medical Devices·50 affected·Aug 9, 2024
High RiskFDA
Wipro Ge Healthcare Private Ltd.
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047...
Medical Devices·137 affected·Aug 9, 2024
High RiskFDA
Physio-control, Inc.
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicat...
Cardiac Devices·3,617 affected·Aug 9, 2024
High RiskFDA
Kester Foods Llc
Yummy Monkey Organics Butter & Yeast Popcorn, Made With Purified Ghee & Nutritional Yeast. UPC 9 96692 66641 2, packaged in a Clear Poly...
Dairy·365 affected·Aug 8, 2024
High RiskFDA
Kester Foods Llc
Yummy Monkey Organics Real Movie Theater Popcorn, Made With Purified Ghee & Himalayan Sea Salt. UPC 9 96692 66654 2, packaged in a Clear...
Snacks & Candy·165 affected·Aug 8, 2024
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 059...
Topical Drugs·7,080 affected·Aug 8, 2024
High RiskFDA
Preferred Pharmaceuticals, Inc.
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, ...
Oral Drugs·266 affected·Aug 8, 2024
High RiskFDA
Zimmer Gmbh
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral an...
Medical Devices·58 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Solo. Digital Mobile C-arm
Medical Devices·28 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Medical Devices·25 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Medical Devices·30 affected·Aug 8, 2024
High RiskFDA
Alcon Research Llc
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Medical Devices·92,835 affected·Aug 8, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Medical Devices·6 affected·Aug 8, 2024
High RiskFDA
Ge Healthcare Gmbh
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; sys...
Medical Devices·574 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision system, x-ray, tomography, computed.
Medical Devices·3 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Medical Devices·5 affected·Aug 8, 2024
High RiskFDA
American Contract Systems, Inc.
Pacemaker, COPM11B; Medical convenience kit
Cardiac Devices·3 affected·Aug 7, 2024
High RiskFDA
Cook Biotech, Inc.
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number ...
Medical Devices·120 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Hand Pack, AKHD97C; Medical convenience kit
Medical Devices·2 affected·Aug 7, 2024
High RiskFDA
Cook Biotech, Inc.
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Nu...
Medical Implants·3 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Vaginal Delivery, ASDV25B; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
Howmedica Osteonics Corp.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Medical Devices·897 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
IR Procedure Pack, CEAT19W; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Medical Devices·57 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
PACEMAKER PACK, SLCV01J; Medical convenience kit
Cardiac Devices·20 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Neuro Vascular, ANKV91A; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Medical Devices·18 affected·Aug 7, 2024
High RiskFDA
Cook Biotech, Inc.
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order N...
Medical Implants·3 affected·Aug 7, 2024
High RiskFDA
Cook Biotech, Inc.
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Orde...
Medical Implants·130 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Medical Devices·504 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Cath Lab Pack, CECL02P; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warm...
Respiratory Devices·944 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit
Medical Devices·93 affected·Aug 7, 2024
High RiskFDA
Biofire Diagnostics, Llc
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Medical Devices·1,001 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Shoulder, SESH18I; Medical convenience kit
Medical Devices·60 affected·Aug 7, 2024
High RiskFDA
Cook Biotech, Inc.
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order N...
Medical Implants·8 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Cysto, FTCY03L; Medical convenience kit
Medical Devices·36 affected·Aug 7, 2024
High RiskFDA
Cook Biotech, Inc.
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order ...
Medical Implants·35 affected·Aug 7, 2024
High RiskFDA
Dr. Reddy's Laboratories, Inc.
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-...
Oral Drugs·103,298 affected·Aug 6, 2024
High RiskFDA
Dr. Reddy's Laboratories, Inc.
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111...
Oral Drugs·14,940 affected·Aug 6, 2024