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CriticalFDA
Tenacore Llc
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Medical Devices·1,494 affected·Feb 25, 2021
CriticalFDA
Mediterranean Food, Inc.
Alqosh Sesame Oil "Tahin" packaged in 2lb plastic jars
Food·140 affected·Feb 24, 2021
RecallFDA
Microbiologics Inc
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Medical Devices·47 affected·Feb 24, 2021
High RiskFDA
Access Vascular, Inc.
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Surgical Devices·79 affected·Feb 24, 2021
RecallFDA
Microbiologics Inc
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Medical Devices·65 affected·Feb 24, 2021
High RiskFDA
Arthrex, Inc.
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Medical Devices·9 affected·Feb 24, 2021
High RiskFDA
Trinity Sterile, Inc.
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dres...
Surgical Devices·2,970 affected·Feb 23, 2021
RecallFDA
Sun Pharmaceutical Industries Inc
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactur...
Ophthalmic Drugs·37,400 affected·Feb 22, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction o...
Surgical Devices·337 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·18 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replac...
Medical Implants·102 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:...
Surgical Devices·19 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, ti...
Medical Devices·355 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:D...
Surgical Devices·13 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace th...
Medical Devices·102 affected·Feb 22, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access...
Medical Implants·267 affected·Feb 22, 2021
High RiskFDA
Sirtex Medical Limited
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Medical Devices·3,310 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·15 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CE...
Surgical Devices·100 affected·Feb 22, 2021
High RiskFDA
Coolhaus
Coolhaus Awesome Dessert - Dairy Free Mocha Marcona Almond Fudge, Creamy Coffee Fudge Swirl & Marcona Almond Frozen Dessert. 16 fl.oz, ...
Dairy·432 affected·Feb 19, 2021
RecallFDA
The Sapphire Exchange
YUM CRUMBS, STRAWBERRY SHORTCAKE, 12 oz and 32 oz
Bakery & Grains·3,421 affected·Feb 19, 2021
High RiskFDA
Green City Distribution
Al-Riyan Tuna Meat in Vegetable oil 7 oz. can 48 cans per case
Meat & Poultry·1,320 affected·Feb 19, 2021
High RiskFDA
Urban Remedy
Urban Remedy Organic Cacao Mocha Cold Brew Coffee; 16 FL. OZ (473 mL) UPC" 8 13377 02222 9 Ingredients: Cashew Milk (filtered water, c...
Dairy·208 affected·Feb 19, 2021
Medium RiskFDA
Jubilant Cadista Pharmaceuticals, Inc.
Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD...
Oral Drugs·635,400 affected·Feb 19, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, ...
Oral Drugs·10,440 affected·Feb 19, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene...
Topical Drugs·934,140 affected·Feb 19, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polyprop...
Topical Drugs·551,670 affected·Feb 19, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropyle...
Topical Drugs·473,280 affected·Feb 19, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene...
Topical Drugs·786,900 affected·Feb 19, 2021
High RiskFDA
Bakeryworks Llc
UnTortillas Grain Free * 3 g of non-fibre carbs * 210g 6 tortillas per bag, 8 packages per case. UPC# 40628250179024 packaged in flexibl...
Food·471 affected·Feb 18, 2021
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packa...
Injectable Drugs·816 affected·Feb 18, 2021
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packag...
Injectable Drugs·1,638 affected·Feb 18, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemi...
Medical Devices·7,546 affected·Feb 18, 2021
High RiskFDA
Teleflex Medical Inc
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during trache...
Medical Devices·157 affected·Feb 18, 2021
CriticalFDA
Smisson-cartledge Biomedical, Llc
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for i...
Medical Devices·7,118 affected·Feb 18, 2021
CriticalFDA
Smisson-cartledge Biomedical, Llc
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for i...
Medical Devices·11,768 affected·Feb 18, 2021
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Medical Devices·496 affected·Feb 18, 2021
CriticalFDA
El Abuelito Cheese, Inc.
Quseo Fresco sold under the following brands and container sizes - El Abuelito Cheese Brand - Queso Fresco Regular 12 oz.Plastic Contai...
Dairy·0 affected·Feb 17, 2021
CriticalFDA
El Abuelito Cheese, Inc.
Quesillo sold under the following brands and container sizes: El Abuelito Cheese Quesillo Abuelito 12oz Vacuum Pack 673130200000 Quesill...
Dairy·0 affected·Feb 17, 2021
High RiskFDA
Giant Eagle
Market District Gourmet Pretzel Gift Bag PLU 45505 Net Wt 9 oz Market District Gourmet Pretzel Platter PLU 25206 Net Wt 48 oz
Food·192 affected·Feb 17, 2021
CriticalFDA
El Abuelito Cheese, Inc.
Requeson/Ricotta, sold under the following brands and container sizes: El Abuelito Requeson Ricotta 12oz Clam Shell Container, UPC: 67313...
Food·0 affected·Feb 17, 2021
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 u...
Oral Drugs·1,350 affected·Feb 17, 2021
High RiskFDA
The General Hospital Corporation
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusett...
Injectable Drugs·50 affected·Feb 17, 2021
RecallFDA
Edge Pharma, Llc
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercu...
Drugs·213 affected·Feb 17, 2021
High RiskFDA
Vectornate Usa Inc
MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Produc...
Medical Devices·130,000 affected·Feb 16, 2021
High RiskFDA
Clerio Vision
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity...
Medical Devices·153 affected·Feb 16, 2021
RecallFDA
Minnesota Milk Bank For Babies
MN Milk Bank for Babies Pasteurized Donor Human Milk. Volumne 4.0 fl oz., 120 mL
Dairy·63 affected·Feb 15, 2021
CriticalFDA
Adams.secret.co
Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
Drugs·0 affected·Feb 15, 2021