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High RiskFDA
Merit Medical Systems, Inc.
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Medical Devices·2,779 affected·Jun 5, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Medical Devices·3,266 affected·Jun 4, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Medical Devices·3,435 affected·Jun 4, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20. Fluoroscopic X-Ray System.
Medical Devices·78 affected·Jun 4, 2025
High RiskFDA
Becton, Dickinson And Company, Bd Bio Sciences
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Medical Devices·278 affected·Jun 3, 2025
High RiskFDA
Icu Medical, Inc.
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Medical Devices·1,445,600 affected·Jun 3, 2025
High RiskFDA
C.r. Bard Inc
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Medical Devices·63 affected·Jun 3, 2025
High RiskFDA
C.r. Bard Inc
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Medical Devices·0 affected·Jun 3, 2025
High RiskFDA
La Fontanella Food Products Llc
Pizza Shoppe The "Pink Stuff" World-Famous Creamy Garlic Salad Dressing, net wt. 12oz, UPC 896537002019 packaged in clear plastic bottle ...
Produce·992 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Offic...
Injectable Drugs·23,200 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Cauda...
Injectable Drugs·2,825 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use ...
Injectable Drugs·14,725 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For ...
Injectable Drugs·975 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Includi...
Injectable Drugs·29,700 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Pres...
Injectable Drugs·4,875 affected·Jun 2, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 So...
Medical Devices·20 affected·Jun 2, 2025
High RiskFDA
Medshape, Inc.
Medshape Universal Joints, REF: DNE-9000-UJ
Medical Devices·849 affected·Jun 2, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 So...
Medical Devices·20 affected·Jun 2, 2025
High RiskFDA
Nature's Eudos Distributors Llc
Eudos Bronquilan
Food·700 affected·Jun 1, 2025
High RiskFDA
Firehook Of Virginia
FIREHOOK ARTISAN BAKED CRACKERS CLASSIC SEA SALT NET WT. 8 OZ (227g) INGREDIENTS: ORGANIC WHEAT FLOUR, ORGANIC HONEY, YEAST, SALT, ORGANI...
Bakery & Grains·525 affected·May 30, 2025
High RiskFDA
Advanced Pharmaceutical Technology, Inc.
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only,...
Injectable Drugs·26 affected·May 30, 2025
High RiskFDA
Eugia Us Llc
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, ...
Injectable Drugs·48,000 affected·May 29, 2025
High RiskFDA
Philips North America Llc
Spectral CT. Computed tomography X-ray system.
Medical Devices·370 affected·May 29, 2025
High RiskFDA
The Coca-cola Company
Topo Chico MINERAL WATER CARBONATED 16.9 FL OZ (500mL) Bottle UPC 0 21136 18061 9, Case UPC 0 21136 18062 6 MADE IN MEXICO BY: CIA. TOPO ...
Beverages·241 affected·May 28, 2025
High RiskFDA
Post Consumer Brands, Llc
Post Honey Bunches of Oats with Almonds. Sweetened Cereal with Oats and Honey. Net Wt 48 oz (3 lbs) 1.36kg. 2 Bags inside for freshness...
Bakery & Grains·5,376 affected·May 28, 2025
High RiskFDA
Camerican International Inc
Casa Mamita, Churro Bites Filled with Chocolate Hazelnut Cream, 7.5 oz , Cardboard Box, 12 boxes per case, Keep Frozen Until Ready For Use
Dairy·19,080 affected·May 28, 2025
High RiskFDA
Apotex Corp.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufa...
Ophthalmic Drugs·87,840 affected·May 28, 2025
High RiskFDA
Apotex Corp.
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for...
Ophthalmic Drugs·105,456 affected·May 28, 2025
High RiskFDA
Pfizer Inc.
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Us...
Injectable Drugs·98,410 affected·May 28, 2025
High RiskFDA
Apotex Corp.
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured fo...
Oral Drugs·20,648 affected·May 28, 2025
High RiskFDA
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Onta...
Ophthalmic Drugs·6,288 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips eL18-4 EMT Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Vers...
Medical Devices·400 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips C9-5EC Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Vers...
Medical Devices·200 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips eL18-4 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips C5-2 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips L12-3 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X6-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X8-2t Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Medical Devices·28 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips V6-2 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips S5-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Vers...
Medical Devices·36 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips S7-2 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips 3D9-3v Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X7-2t Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X5-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025