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High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Medical Devices·550 affected·Dec 16, 2022
High RiskFDA
Access Vascular, Inc
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Medical Devices·0 affected·Dec 16, 2022
High RiskFDA
Carbon Medical Technologies, Inc.
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Medical Devices·550 affected·Dec 16, 2022
High RiskFDA
Novasignal Corp.
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and L...
Medical Devices·4 affected·Dec 16, 2022
High RiskFDA
Access Vascular, Inc
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Medical Devices·1,789 affected·Dec 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 ...
Medical Devices·609 affected·Dec 16, 2022
High RiskFDA
Pietrzyk Foods
PIETRZYK PIEROGI THE HOLY GOUDA PIEROGI, NET WT. 26.5oz (742g), 1 DOZEN UPC 850014236069
Food·39 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujili...
Drugs·8,475 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 013...
Drugs·12,130 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, ...
Drugs·65,376 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo A...
Drugs·144 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catan...
Drugs·124 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7
Drugs·164 affected·Dec 15, 2022
High RiskFDA
Frenda Corporation
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) R...
Drugs·44,140 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Medical Devices·250 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Medical Devices·112,675 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Medical Devices·76,260 affected·Dec 15, 2022
High RiskFDA
Teknimed Sas
HIGH V+ Spinal Cement System REF T040321K
Medical Devices·236 affected·Dec 15, 2022
High RiskFDA
Meridian Bioscience Inc
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Medical Devices·92 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Medical Devices·80 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Medical Devices·200 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Medical Devices·275 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Surgical Devices·920 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Medical Devices·200 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Medical Devices·300 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Medical Devices·2,779 affected·Dec 15, 2022
High RiskFDA
Medtronic Navigation, Inc.
AxiEM" Non-Invasive Patient Tracker
Medical Devices·1,867 affected·Dec 15, 2022
High RiskFDA
Biomet, Inc.
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femo...
Medical Devices·7 affected·Dec 15, 2022
High RiskFDA
Coopersurgical, Inc.
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagno...
Medical Implants·489 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0...
Medical Devices·21,755 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Medical Devices·2,500 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Medical Devices·1,175 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Medical Devices·1,040 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Medical Devices·180 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Medical Devices·600 affected·Dec 15, 2022
High RiskFDA
W L Gore & Associates, Inc.
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Medical Devices·14 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
Medical Devices·0 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
Medical Devices·921 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
Medical Devices·1,920 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
Medical Devices·750 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
Medical Devices·2,259 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
Medical Devices·7,129 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
Medical Devices·892 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
Medical Devices·4,112 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
Medical Devices·3,507 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
Medical Devices·4,111 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
Medical Devices·3,550 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
Medical Devices·1,150 affected·Dec 14, 2022