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High RiskFDA
Micro-x Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Medical Devices·18 affected·Nov 28, 2023
High RiskFDA
Mo-vis Bvba
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuverin...
Medical Devices·129 affected·Nov 28, 2023
High RiskFDA
Atricure, Inc.
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Medical Devices·35 affected·Nov 28, 2023
High RiskFDA
Icotec Ag
VADER pedicle system, torque wrench, Catalog Number 42-702
Medical Devices·79 affected·Nov 28, 2023
High RiskFDA
Xtant Medical Holdings, Inc
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Medical Devices·6 affected·Nov 28, 2023
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Medical Devices·4,235 affected·Nov 28, 2023
High RiskFDA
Trimed Inc.
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N...
Medical Devices·270 affected·Nov 28, 2023
High RiskFDA
Cordis Us Corp
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Medical Devices·50 affected·Nov 28, 2023
High RiskFDA
Atricure, Inc.
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Medical Devices·1 affected·Nov 28, 2023
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Medical Devices·4,224 affected·Nov 28, 2023
High RiskFDA
Philips North America
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Mod...
Medical Devices·41 affected·Nov 28, 2023
High RiskFDA
Natus Medical Incorporated
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Medical Devices·3,336 affected·Nov 28, 2023
High RiskFDA
Natus Medical Incorporated
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Medical Devices·2,686 affected·Nov 28, 2023
High RiskFDA
Acumed Llc
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used w...
Medical Devices·513 affected·Nov 27, 2023
High RiskFDA
Biofire Diagnostics, Llc
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or...
Respiratory Devices·57 affected·Nov 27, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Cal...
Diagnostic Devices·6,920 affected·Nov 27, 2023
High RiskFDA
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perf...
Medical Devices·467 affected·Nov 27, 2023
High RiskFDA
Actim Oy
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Diagnostic Devices·6,471 affected·Nov 23, 2023
High RiskFDA
Lupin Pharmaceuticals Inc.
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactur...
Oral Drugs·0 affected·Nov 22, 2023
High RiskFDA
Anazaohealth Corporation
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las...
Injectable Drugs·3,363 affected·Nov 22, 2023
High RiskFDA
Wells Pharma Of Houston Llc
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-1...
Injectable Drugs·825 affected·Nov 22, 2023
High RiskFDA
Anazaohealth Corporation
B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Do...
Injectable Drugs·5,707 affected·Nov 22, 2023
High RiskFDA
Deroyal Industries Inc
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Cardiac Devices·252 affected·Nov 22, 2023
High RiskFDA
Willamette Valley Pie Company, Llc
Bulk Frozen Cases: The 9" Vegan Pumpkin Pie bulk case has UPC 22518 84081 and the label is read in parts: 9" Vegan Pumpkin Pie WFM, BAKED...
Frozen Food·254 affected·Nov 21, 2023
High RiskFDA
Beckman Coulter, Inc.
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Diabetes Devices·19,125 affected·Nov 21, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
QMS Tacrolimus Calibrators, Product code 10015573
Medical Devices·10 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
AcuMatch Hip System, Catalog Number 142-32-27
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f)...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e)...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Sheetz Distribution Services, Llc
Top Label Reads: SHEETZ M.T.go! Made"To"Go DOUBLE DIPPED CHOCOLATEY PEANUT BUTTER PEANUTS SNAX MIX NET WT 6.55 OZ (186 G) Back Panel Read...
Dairy·207 affected·Nov 20, 2023
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, docu...
Surgical Devices·1,403 affected·Nov 20, 2023
High RiskFDA
Medtronic Inc.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medical Implants·1 affected·Nov 20, 2023
High RiskFDA
Randox Laboratories Ltd.
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Diagnostic Devices·108 affected·Nov 20, 2023
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Medical Devices·98 affected·Nov 20, 2023
High RiskFDA
Keystone Industries
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, rep...
Medical Devices·336 affected·Nov 20, 2023
High RiskFDA
Randox Laboratories Ltd.
Calibration Serum Level 3 CAL2351
Medical Devices·269 affected·Nov 20, 2023
High RiskFDA
Thor Photomedicine Ltd
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
Medical Devices·61 affected·Nov 20, 2023
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, docume...
Surgical Devices·271 affected·Nov 20, 2023
High RiskFDA
Dianne's Fine Desserts
Sienna Bakery Chocolate Decadent Brownies (Tray)
Snacks & Candy·512 affected·Nov 18, 2023
High RiskFDA
Stonewall Kitchen, Llc
Vermont Village Organic Unsweetened Apple Sauce (24oz); UPC 362401 | 084648311285
Food·13,086 affected·Nov 17, 2023
High RiskFDA
Publix Super Markets, Inc.
EGG CUSTARD PIE, NET WT 25 OZ (1 LB 9 OZ) 709 g, packaged in paper carton with plastic film window, 6 cartons per case.
Food·1,100 affected·Nov 16, 2023
High RiskFDA
Steris Corporation
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through ...
Medical Devices·4,214 affected·Nov 16, 2023
High RiskFDA
Covidien Lp
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in ...
Medical Implants·54 affected·Nov 16, 2023