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High RiskFDA
Medtronic Navigation, Inc.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is in...
Surgical Devices·1,801 affected·Aug 22, 2024
High RiskFDA
Healgen Scientific Llc
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing...
Diabetes Devices·1,636,994 affected·Aug 22, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion...
Medical Devices·7,091 affected·Aug 22, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722...
Medical Devices·250 affected·Aug 22, 2024
High RiskFDA
Orwaiian Llc
BDAY CAKE MOCHI CRUNCH packed in pink plastic pouch packaging, net wt. 5oz, UPC 7189147148, Orwaiian LLC, 465 NE Burnside Rd Gresham, OR ...
Dairy·720 affected·Aug 21, 2024
High RiskFDA
Inner Waymark Llc
Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt. 16oz (454g). Packaged in Kraft paper heat sealed stand-up ...
Snacks & Candy·60 affected·Aug 21, 2024
High RiskFDA
My Chai Inc
MyChai Chai Tea Concentrate Original. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is induction seal...
Dairy·19,061 affected·Aug 21, 2024
High RiskFDA
My Chai Inc
MyChai Chai Tea Concentrate KALI, 68 fl. oz. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is inducti...
Dairy·4,545 affected·Aug 21, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland ...
Oral Drugs·4,554 affected·Aug 21, 2024
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Medical Devices·144 affected·Aug 21, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Medical Devices·1,407 affected·Aug 21, 2024
High RiskFDA
Change Healthcare Canada Company
Horizon Cardiology Hemo. Version 12.2.
Medical Devices·3 affected·Aug 21, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Diagnostic Devices·9,783 affected·Aug 21, 2024
High RiskFDA
Cypress Medical Products Llc
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Respiratory Devices·15 affected·Aug 20, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Medical Devices·16,439 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K0...
Medical Devices·7,099 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixSKY Inflation Device, REF: SKY1802
Medical Devices·70 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Medical Devices·12,910 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Medical Devices·290 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Medical Devices·14,120 affected·Aug 19, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manne...
Medical Devices·60 affected·Aug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient man...
Medical Devices·40 affected·Aug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient mann...
Medical Devices·642 affected·Aug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient mann...
Medical Devices·180 affected·Aug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient m...
Medical Devices·894 affected·Aug 16, 2024
High RiskFDA
Refresco Beverages Us Inc
Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged in 8 oz. PET plastic bottles; UPC 0-78742-29655-5
Beverages·9,535 affected·Aug 15, 2024
High RiskFDA
Fagron Compounding Services
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, K...
Injectable Drugs·0 affected·Aug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Medical Devices·180 affected·Aug 15, 2024
High RiskFDA
B Braun Medical Inc
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model...
Medical Devices·10,658,351 affected·Aug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Medical Devices·192,964 affected·Aug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/...
Medical Devices·4,984,920 affected·Aug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/...
Medical Devices·4,671,540 affected·Aug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Mo...
Medical Devices·9,864,165 affected·Aug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: ...
Medical Devices·142,336 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic...
Diagnostic Devices·7,022 affected·Aug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Medical Devices·10,460 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: ...
Diagnostic Devices·321 affected·Aug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Medical Devices·125,017 affected·Aug 15, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA C...
Diagnostic Devices·18,483 affected·Aug 15, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Diagnostic Devices·1,990 affected·Aug 15, 2024
High RiskFDA
Authentik Fudge
Montreal Fudge brand Chocolate Fudge with Nuts; 5.6oz
Snacks & Candy·84 affected·Aug 14, 2024
High RiskFDA
Now Foods
NOW Real Foods Whole & Unsalted Raw Brazil Nuts 12oz. bag UPC 733739070128
Food·7,854 affected·Aug 14, 2024
High RiskFDA
Innovasis, Inc
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device inten...
Medical Devices·568 affected·Aug 14, 2024
High RiskFDA
3m Company - Health Care Business
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Medical Devices·10,000 affected·Aug 14, 2024
High RiskFDA
Zoe Medical Incorporated
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Medical Devices·6,429 affected·Aug 13, 2024
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