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High RiskFDA
Pharmadel, Llc
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99
Oral Drugs·6,048 affected·Apr 15, 2025
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Medical Devices·6,961 affected·Apr 15, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Medical Devices·2,212 affected·Apr 15, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Medical Devices·1,072 affected·Apr 15, 2025
High RiskFDA
Megamex Foods Llc
La Victoria Cilantro Salsa; Med; Net Wt 15.5 OZ; UPC# 0 72101 34470 3; Distributed by: Megamex Foods, LLC Orange, CA 92868
Food·501 affected·Apr 14, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distribute...
Oral Drugs·16,473 affected·Apr 14, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx O...
Oral Drugs·343,344 affected·Apr 14, 2025
CriticalFDA
Saini Trade Inc
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Oral Drugs·300 affected·Apr 14, 2025
CriticalFDA
Saini Trade Inc
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Oral Drugs·500 affected·Apr 14, 2025
CriticalFDA
Saini Trade Inc
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Oral Drugs·300 affected·Apr 14, 2025
CriticalFDA
Saini Trade Inc
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Oral Drugs·500 affected·Apr 14, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major...
Oral Drugs·133 affected·Apr 14, 2025
CriticalFDA
Saini Trade Inc
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Oral Drugs·3,000 affected·Apr 14, 2025
High RiskFDA
Prismatik Dentalcraft, Inc.
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewel...
Medical Implants·15 affected·Apr 14, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Medical Devices·3,587 affected·Apr 14, 2025
High RiskFDA
Jj Nuts, Llc
MAGIC FLAME, HULLED SUNFLOWER KERNELS, BAKERY GRADE, 501b. Bag, Three ply Paper bags, 1100 Paper bags x 50 Ib. on 20 pallets. Store in dr...
Food·560 affected·Apr 13, 2025
High RiskFDA
Microtek Medical, Inc.
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Dr...
Medical Devices·2,024 affected·Apr 13, 2025
High RiskFDA
Upper Crust Bakery Lp
Multigrain Sourdough , 18 oz, Paper carton (corrugated), CP12, Frozen
Frozen Food·699 affected·Apr 12, 2025
High RiskFDA
Giant Eagle, Inc.
Multigrain Sourdough Freshly Backed, and Half Multigrain Sourdough Artisan Bread, 15 oz; 7 oz, Bag, 1 unit
Bakery & Grains·240 affected·Apr 12, 2025
High RiskFDA
Upper Crust Bakery Lp
Ancient Grains Hoagie Roll, 4 oz, Paper carton (corrugated), CP45, Frozen
Frozen Food·89 affected·Apr 12, 2025
High RiskFDA
Upper Crust Bakery Lp
Whole Grain Multigrain , 20 oz, Paper carton (corrugated), CP12, Frozen
Frozen Food·30 affected·Apr 12, 2025
High RiskFDA
Dianne's Fine Desserts
Outer carton labeled: "Cookie Butter Banana Pie" Inner carton labeled: "Tropical Key Lime Pie" Product contained inside: "Cookie Butter ...
Dairy·1,191 affected·Apr 12, 2025
High RiskFDA
Emily Kate's Foods
Emily Kate's Gluten Free Vanilla Cake, Net Wt. 6.4oz, Emily Kate's Foods, Kansas City, KS 66106, UPC 850581007253
Bakery & Grains·1,140 affected·Apr 11, 2025
High RiskFDA
Emily Kate's Foods
Emily Kate's Gluten Free Carrot Cake, Net Wt. 6.4oz, Emily Kate's Food, LLC, Kansas City, KS 66106, UPC 850581007284
Bakery & Grains·1,140 affected·Apr 11, 2025
CriticalFDA
Centerline Biomedical Inc
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a cath...
Surgical Devices·80 affected·Apr 11, 2025
CriticalFDA
Integra Lifesciences Corp. (neurosciences)
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Medical Devices·1,840 affected·Apr 11, 2025
CriticalFDA
Medical Depot Inc.
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a ve...
Respiratory Devices·89,532 affected·Apr 11, 2025
CriticalFDA
Momo Tea Inc
MO-CHA brand Premium Non-Dairy Creamer; INGREDIENTS Glucose syrup, Refined vegetable oil, Whey powder, Sugar, Casein, Emulsifier (471, 48...
Dairy·4,500 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617,...
Oral Drugs·4,885 affected·Apr 10, 2025
High RiskFDA
Eugia Us Llc
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, M...
Injectable Drugs·36,816 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, ...
Oral Drugs·18,984 affected·Apr 10, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 2...
Oral Drugs·2,724 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, ...
Oral Drugs·4,872 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617,...
Oral Drugs·4,888 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUA...
Medical Devices·185,975 affected·Apr 10, 2025
CriticalFDA
3m Company
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Medical Devices·530,470 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-...
Medical Devices·185,975 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 2...
Medical Devices·313,676 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) P...
Medical Devices·313,676 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD Solis HSPCA Pump
Medical Devices·83,833 affected·Apr 10, 2025
CriticalFDA
Vyaire Medical
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Descri...
Respiratory Devices·1,895 affected·Apr 10, 2025
High RiskFDA
Tornier S.a.s.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Surgical Devices·438 affected·Apr 10, 2025
High RiskFDA
Apipharma
Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distribu...
Topical Drugs·4,218 affected·Apr 9, 2025
High RiskFDA
Cardinal Health Inc.
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose ...
Injectable Drugs·48 affected·Apr 9, 2025
High RiskFDA
Apipharma
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10...
Topical Drugs·5,095 affected·Apr 9, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Medical Devices·840 affected·Apr 9, 2025
High RiskFDA
Foundation Medicine, Inc.
FoundationOne Companion Diagnostic (F1CDx)
Diagnostic Devices·4 affected·Apr 9, 2025
CriticalFDA
Richard Wolf Gmbh
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with pie...
Medical Devices·31 affected·Apr 9, 2025