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High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a d...
Diagnostic Devices·3,145 affected·Oct 16, 2020
High RiskFDA
Ra Medical Systems, Inc.
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: ...
Medical Devices·36 affected·Oct 16, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic ...
Diagnostic Devices·2,838 affected·Oct 13, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic A...
Diagnostic Devices·2,838 affected·Oct 13, 2020
High RiskFDA
Nurture Inc. Dba Happy Family
Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & Raspberry. SKU: KB-BLRB-5. Ready-to-eat granola bar intended for toddler cons...
Bakery & Grains·9,959 affected·Oct 12, 2020
High RiskFDA
Nurture Inc. Dba Happy Family
Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, Strawberries, & Sunflower Butter. SKU: TB-BASTSB-5 and TB-BASTSB-5-WM. Ready...
Dairy·18,196 affected·Oct 12, 2020
High RiskFDA
Nurture Inc. Dba Happy Family
Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & Oatmeal. SKU: TB-BLOT-5 and TB-BLOT-5-WM. Ready-to-eat granola bar inten...
Bakery & Grains·16,663 affected·Oct 12, 2020
High RiskFDA
Direct Rx
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Drugs·88 affected·Oct 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe t...
Surgical Devices·15 affected·Oct 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe...
Surgical Devices·3 affected·Oct 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, dispos...
Surgical Devices·37 affected·Oct 12, 2020
High RiskFDA
Roi Cps Llc
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Medical Devices·220 affected·Oct 12, 2020
High RiskFDA
Remedyrepack Inc.
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 7051...
Drugs·79 affected·Oct 11, 2020
High RiskFDA
Jarrow Formulas Inc
N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
Oral Drugs·533 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UP...
Drugs·7,591 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories,...
Drugs·1,225 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
Drugs·198 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz ...
Drugs·5,312 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
Drugs·2,638 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Drugs·927 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Topical Drugs·2,335 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
Topical Drugs·1,608 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
Drugs·4,855 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
Drugs·2,655 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 35...
Drugs·4,878 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357...
Drugs·1,815 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, Ne...
Topical Drugs·2,664 affected·Oct 9, 2020
High RiskFDA
Milbar Laboratories, Inc.
(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 m...
Drugs·3,692 affected·Oct 9, 2020
High RiskFDA
Primus Corporation
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Medical Devices·97 affected·Oct 9, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configu...
Medical Devices·40 affected·Oct 9, 2020
High RiskFDA
Denton Pharma, Inc.
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count...
Oral Drugs·684 affected·Oct 8, 2020
High RiskFDA
Denton Pharma, Inc.
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Ph...
Oral Drugs·0 affected·Oct 8, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and ...
Cardiac Devices·14 affected·Oct 8, 2020
High RiskFDA
Enterix, Inc.
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal sample...
Medical Devices·5,256 affected·Oct 8, 2020
High RiskFDA
Microbiologics Inc
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance ...
Diagnostic Devices·46 affected·Oct 8, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1,...
Medical Devices·2,768 affected·Oct 8, 2020
High RiskFDA
Microbiologics Inc
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is s...
Medical Devices·1 affected·Oct 8, 2020
High RiskFDA
Baxter Healthcare Corporation
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured...
Injectable Drugs·0 affected·Oct 7, 2020
High RiskFDA
Ariola Foods Corp.
Frozen raw Lobster Tail pastry 100 count, sold in 15LB, 24LB, 40.25LB cases
Seafood·0 affected·Oct 6, 2020
High RiskFDA
Wolfgang Confectioners
Hu Cashew Hunks, Hu Cashews + Vanilla Bean Chocolate Covered Hunks 4 oz., stand up pouch, 6 bags per case .
Snacks & Candy·136 affected·Oct 6, 2020
High RiskFDA
Wolfgang Confectioners
Hu Almond Hunks, Almonds + Sea Salt Chocolate Covered Hunks 4 oz., stand up pouch, 6 bags per case .
Snacks & Candy·136 affected·Oct 6, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60...
Oral Drugs·125 affected·Oct 6, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablet...
Oral Drugs·1,683 affected·Oct 6, 2020
High RiskFDA
Exactech, Inc.
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Medical Devices·69 affected·Oct 6, 2020
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. ...
Oral Drugs·13,270 affected·Oct 5, 2020
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. ...
Oral Drugs·0 affected·Oct 5, 2020
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. ...
Oral Drugs·0 affected·Oct 5, 2020
High RiskFDA
Micro-tech Usa
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endo...
Medical Devices·2,420 affected·Oct 5, 2020