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High RiskFDA
Teva Pharmaceuticals Usa, Inc
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis ...
Drugs·113,943 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/P...
Medical Devices·4,225,160 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ4872...
Medical Devices·3,290 affected·Mar 19, 2026
CriticalFDA
Boston Scientific Corporation
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL M...
Cardiac Devices·685,776 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Medical Devices·104 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
Medical Devices·160 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU D...
Medical Devices·924 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU ...
Medical Devices·632 affected·Mar 19, 2026
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Medical Devices·226 affected·Mar 19, 2026
CriticalFDA
American Contract Systems Inc
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA8...
Medical Devices·7,311 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU ...
Medical Devices·1,824 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CD...
Medical Devices·21,288 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
Medical Devices·120 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
Medical Devices·340 affected·Mar 19, 2026
CriticalFDA
Boston Scientific Corporation
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO ...
Medical Implants·718,456 affected·Mar 19, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in co...
Medical Devices·1,033 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
Diagnostic Devices·263,739 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Medical Devices·1,552,486 affected·Mar 19, 2026
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Medical Devices·148 affected·Mar 19, 2026
CriticalFDA
B Braun Medical Inc
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Medical Devices·328,640 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU...
Medical Devices·4,324 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
Medical Devices·306 affected·Mar 19, 2026
High RiskFDA
Elekta, Inc.
Brand Name: Leksell Vantage Arc System REF: 1053958
Medical Devices·768 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNS...
Medical Devices·10,400 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU...
Cardiac Devices·4,016 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU D...
Medical Devices·9,805 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479;...
Medical Devices·413 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU...
Medical Devices·1,294 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Numb...
Medical Devices·208 affected·Mar 19, 2026
RecallFDA
Island Kinetics, Inc. D.b.a. Covalence Laboratories
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Topical Drugs·1,060 affected·Mar 18, 2026
CriticalFDA
Amneal Pharmaceuticals, Llc
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufa...
Injectable Drugs·784 affected·Mar 18, 2026
RecallFDA
Island Kinetics, Inc. D.b.a. Covalence Laboratories
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75...
Topical Drugs·299 affected·Mar 18, 2026
RecallFDA
Island Kinetics, Inc. D.b.a. Covalence Laboratories
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW ...
Topical Drugs·2,895 affected·Mar 18, 2026
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Diagnostic Devices·18,080 affected·Mar 18, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured i...
Injectable Drugs·19,869 affected·Mar 17, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured i...
Injectable Drugs·1,897 affected·Mar 17, 2026
High RiskFDA
Nephron Sc, Llc
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing fa...
Drugs·146,280 affected·Mar 17, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured i...
Injectable Drugs·21,930 affected·Mar 17, 2026
High RiskFDA
Viatris, Inc.
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV ...
Oral Drugs·0 affected·Mar 17, 2026
High RiskFDA
Chiesi Usa, Inc.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510...
Drugs·7,235 affected·Mar 17, 2026
High RiskFDA
Straumann Usa Llc
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Medical Devices·13 affected·Mar 17, 2026
High RiskFDA
Albertsons Companies Llc
Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and keep refrigerated. Consumer package ...
Dairy·12,222 affected·Mar 16, 2026
RecallFDA
Pocas International Corp.
POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ
Beverages·148 affected·Mar 16, 2026
RecallFDA
Pocas International Corp.
POPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ
Beverages·425 affected·Mar 16, 2026
RecallFDA
Pocas International Corp.
POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ
Beverages·517 affected·Mar 16, 2026
RecallFDA
Pocas International Corp.
POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ
Beverages·370 affected·Mar 16, 2026
High RiskFDA
Cipla Usa, Inc.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactur...
Oral Drugs·113,336 affected·Mar 16, 2026
High RiskFDA
Cipla Usa, Inc.
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactur...
Oral Drugs·63,192 affected·Mar 16, 2026