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High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·451 affected·Oct 25, 2023
High RiskFDA
Riverpoint Medical, Llc
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF...
Medical Devices·999 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·47 affected·Oct 25, 2023
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Medical Devices·464 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·1,019 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·315 affected·Oct 25, 2023
High RiskFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Medical Devices·2 affected·Oct 24, 2023
High RiskFDA
Graphenano Dental Sl
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichrom...
Medical Devices·354 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Medical Devices·990 affected·Oct 24, 2023
High RiskFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Medical Devices·4 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, RE...
Medical Devices·4,878 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, ...
Medical Devices·4,470 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Medical Devices·1,127 affected·Oct 24, 2023
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2,...
Oral Drugs·16,944 affected·Oct 23, 2023
High RiskFDA
Sage Products Inc
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Medical Devices·174,960 affected·Oct 23, 2023
High RiskFDA
Nutricia North America
Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*
Food·283 affected·Oct 20, 2023
High RiskFDA
Give And Go Prepared Foods Corp
Item 19858, Amazon Fresh, Frosted Mini Brownie with yellow and purple icing with sprinkles, 12 count per pack, packaged in a plastic clea...
Food·1,961 affected·Oct 20, 2023
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, N...
Oral Drugs·5,856 affected·Oct 20, 2023
High RiskFDA
Omega & Delta Co., Inc.
Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
Drugs·4,848 affected·Oct 20, 2023
High RiskFDA
Omega & Delta Co., Inc.
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc...
Drugs·23,136 affected·Oct 20, 2023
High RiskFDA
Itf Pharma Inc
Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., ...
Oral Drugs·1,792 affected·Oct 20, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 0851...
Oral Drugs·7,392 affected·Oct 20, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 085...
Oral Drugs·2,304 affected·Oct 20, 2023
High RiskFDA
Omega & Delta Co., Inc.
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Del...
Drugs·48,145 affected·Oct 20, 2023
High RiskFDA
Nature's Path Foods Inc
Nature's Path Organic Pumpkin Spice Waffles, 7 oz., UPC 0 5844959077 4
Food·6,908 affected·Oct 19, 2023
High RiskFDA
Nature's Path Foods Inc
Nature's Path Organic Dark Chocolate Chip Waffles, 7 oz., UPC 0 5844916701 3
Snacks & Candy·6,707 affected·Oct 19, 2023
High RiskFDA
Garden Of Life Llc
Garden of Life, RM-10 ULTRA, Ultimate Immune System Support60 Vegetarian Caplets, Whole Food Dietary Supplement, 90 Ultra Zorbe Vegetaria...
Supplements·8,940 affected·Oct 19, 2023
High RiskFDA
Garden Of Life Llc
Garden of Life, FYI ULTRA, ULTIMATE Joint & Cartilage Formula, Whole Food Dietary Supplement, 120 Ultra Zorbe VEGETARIAN CAPSULES
Baby Food & Formula·37 affected·Oct 19, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. ...
Oral Drugs·0 affected·Oct 19, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India....
Oral Drugs·0 affected·Oct 19, 2023
High RiskFDA
Safecor Health, Llc
Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA...
Drugs·166,022 affected·Oct 19, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India....
Oral Drugs·0 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Medical Devices·59 affected·Oct 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Leg bag, REF URO12573
Medical Devices·144 affected·Oct 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Leg bag, REF DYND12574
Medical Devices·28,942 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the b...
Medical Devices·1,639 affected·Oct 19, 2023
High RiskFDA
Abbott Laboratories
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random ...
Diagnostic Devices·1,325 affected·Oct 19, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW),...
Medical Devices·10,183 affected·Oct 19, 2023
High RiskFDA
Meridian Bioscience Inc
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens co...
Medical Devices·38 affected·Oct 19, 2023
High RiskFDA
Abbott Laboratories
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random an...
Diagnostic Devices·1,127 affected·Oct 19, 2023
High RiskFDA
Meridian Bioscience Inc
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal ...
Medical Devices·201 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Leg bag, REF DYND12578
Medical Devices·19,406 affected·Oct 19, 2023
High RiskFDA
Abbott Laboratories
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-p...
Medical Devices·670 affected·Oct 19, 2023
High RiskFDA
Abbott Laboratories
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module...
Medical Devices·995 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Medical Devices·160 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Medical Devices·510 affected·Oct 19, 2023