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High RiskFDA
Philips Ultrasound, Inc
Philips C5-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips L12-4 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, 22mm Model/Catalog Number: 506-04-122 Software Vers...
Medical Devices·200 affected·May 28, 2025
High RiskFDA
Stryker Gmbh
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Medical Devices·0 affected·May 28, 2025
High RiskFDA
East Africa Boutique, Llc.
Nootri Toto, Net Weight 1 kg, packaged in a cardboard box, packed 12 boxes per case
Food·2 affected·May 27, 2025
High RiskFDA
East Africa Boutique, Llc.
Super Cereal Plus fortified corn soya blend, Net Weight 1.5 kg, packaged in a plastic foil bag, packed 9 bags per case
Bakery & Grains·19 affected·May 27, 2025
High RiskFDA
Torrent Pharma Inc.
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manu...
Oral Drugs·972 affected·May 27, 2025
High RiskFDA
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-3...
Injectable Drugs·3,651,468 affected·May 27, 2025
High RiskFDA
Torrent Pharma Inc.
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactur...
Oral Drugs·3,672 affected·May 27, 2025
High RiskFDA
Microbiologics Inc
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, St...
Medical Devices·3 affected·May 27, 2025
High RiskFDA
Comvita Usa Inc
Comvita branded Manuka Honey + Reishi; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001013
Food·2,730 affected·May 23, 2025
High RiskFDA
Pepsi Beverages Company
Dr. Pepper, ZERO SUGAR, 12 FL OZ (355 mL) ALUMINUM CAN packaged and sold as 12 packs and 24 packs cartons cases. PRODUCED UNDER THE AUTHO...
Produce·19,203 affected·May 23, 2025
High RiskFDA
Comvita Usa Inc
Comvita branded Manuka Honey + Lion's Mane for Focus; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001020
Food·2,730 affected·May 23, 2025
High RiskFDA
Comvita Usa Inc
Comvita branded Manuka Honey + Cordyceps for energy; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001037
Food·2,730 affected·May 23, 2025
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufact...
Oral Drugs·36,612 affected·May 23, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs·10,620 affected·May 23, 2025
High RiskFDA
Consumer Product Partners, Llc
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three La...
Topical Drugs·125,040 affected·May 23, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs·48,936 affected·May 23, 2025
High RiskFDA
Corin Medical, Ltd.
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-5...
Medical Devices·341 affected·May 23, 2025
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect
Medical Devices·0 affected·May 23, 2025
High RiskFDA
Quantum Surgical Sas
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist i...
Medical Devices·4 affected·May 23, 2025
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect AIR
Medical Devices·0 affected·May 23, 2025
High RiskFDA
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Medical Devices·1 affected·May 23, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATI...
Surgical Devices·186 affected·May 23, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Surgical Devices·36 affected·May 23, 2025
High RiskFDA
Aurobindo Pharma Usa Inc
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72...
Oral Drugs·4,608 affected·May 22, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Cardiology Hemodynamics Software
Medical Devices·4 affected·May 22, 2025
High RiskFDA
Stryker Gmbh
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Medical Devices·1 affected·May 22, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Cardiology Hemo Software
Medical Devices·29 affected·May 22, 2025
High RiskFDA
Pain Train Salsa, Llc
Pain Train Salsa - Creamy Avocado Spicy Refrigerated. Shelf Life 90 days. 12 oz Flexible Plastic containers. UPC: 1958...
Food·148 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Drugs·164 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·4 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englew...
Injectable Drugs·216 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·5 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englew...
Drugs·16 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·24 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, ...
Injectable Drugs·242 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Drugs·32 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·60 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, ...
Drugs·102 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-...
Injectable Drugs·64 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewo...
Injectable Drugs·28 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·826 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englew...
Drugs·16 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025