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High RiskFDA
Arg Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bo...
Drugs·3,440 affected·Apr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum...
Topical Drugs·4,013 affected·Apr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sp...
Topical Drugs·6,264 affected·Apr 17, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Gl...
Oral Drugs·3,264 affected·Apr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tu...
Drugs·7,410 affected·Apr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW ...
Drugs·9,697 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices·45,880 affected·Apr 17, 2024
High RiskFDA
Nrt X-ray A/s
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Medical Devices·35 affected·Apr 17, 2024
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Medical Devices·1,822 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·12,292 affected·Apr 17, 2024
High RiskFDA
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Surgical Devices·5,604 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·334 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·931 affected·Apr 17, 2024
High RiskFDA
Cardinal Health 200, Llc
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Medical Devices·2,000 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices·11,371 affected·Apr 17, 2024
High RiskFDA
La Original Tortilla Co., Inc.
Bulk flour tortillas sold to food service. 20ct 6in flour. 12 packages of 20ct per case. Packed in clear plastic bag and cardboard box.
Food·35 affected·Apr 16, 2024
High RiskFDA
S Martinelli & Company
Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Apples 1 Liter (33.8 fl oz.) No Additives of Any Kind UPC 0 00 41244 00102 6
Beverages·24,519 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Medical Implants·14 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Medical Implants·9 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Medical Implants·14 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Medical Implants·5 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Medical Implants·8 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Medical Implants·13 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Medical Implants·36 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Medical Implants·9 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Medical Implants·26 affected·Apr 16, 2024
High RiskFDA
Tornier S.a.s.
Stryker Blueprint Software, Catalog #BPUE001.
Medical Devices·0 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Medical Implants·4 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Medical Implants·2 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Medical Implants·6 affected·Apr 16, 2024
High RiskFDA
Maquet Medical Systems Usa
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Respiratory Devices·148 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·68 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·1,635 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·40 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·20 affected·Apr 15, 2024
High RiskFDA
Detty Family Barbeque Ltd
DB Yummers Island Marinade Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200103.
Food·480 affected·Apr 12, 2024
High RiskFDA
Detty Family Barbeque Ltd
DB Yummers Mildly Spicy Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200102.
Food·7,080 affected·Apr 12, 2024
High RiskFDA
Detty Family Barbeque Ltd
DB Yummers Sweet & Smokey Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 74872001101.
Food·7,548 affected·Apr 12, 2024
High RiskFDA
Dercher Enterprises, Inc., Dba Gordon Laboratories
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
Drugs·5,247 affected·Apr 12, 2024
High RiskFDA
Medartis Inc.
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Medical Devices·110 affected·Apr 12, 2024
High RiskFDA
The James Skinner Co.
Marketside Cinnamon Pecan Braid, Triple-Filled Danish, Filled with Cinnamon Filling, Topped with Pecans, Sweet Icing and Streusel. Net Wt...
Food·4,111 affected·Apr 11, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extr...
Medical Devices·18 affected·Apr 11, 2024
High RiskFDA
Securitas Healthcare Llc
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the...
Medical Devices·661 affected·Apr 11, 2024
High RiskFDA
Feel Good Foods Inc
Cream Cheese Stuffed Plain Mini Bagels
Dairy·4,550 affected·Apr 10, 2024
High RiskFDA
Feel Good Foods Inc
Cream Cheese Stuffed Everything Mini Bagels
Dairy·9,172 affected·Apr 10, 2024
High RiskFDA
Imprimis Njof, Llc
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC...
Ophthalmic Drugs·3,320 affected·Apr 10, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Medical Devices·141 affected·Apr 10, 2024
High RiskFDA
Preat Corp
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixt...
Medical Implants·7 affected·Apr 10, 2024