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High RiskFDA
W L Gore & Associates, Inc.
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent ...
Medical Implants·2 affected·Sep 7, 2021
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Onl...
Oral Drugs·14,904 affected·Sep 3, 2021
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; M...
Oral Drugs·38,748 affected·Sep 3, 2021
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA...
Drugs·116,400 affected·Sep 3, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Medical Devices·507 affected·Sep 3, 2021
High RiskFDA
Flower Orthopedics Corporation
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Medical Devices·77 affected·Sep 3, 2021
High RiskFDA
Monarch Pcm, Llc
Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
Supplements·5,495 affected·Sep 2, 2021
High RiskFDA
Rising Pharmaceuticals
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, M...
Oral Drugs·1,344 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·15 affected·Sep 2, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medical Devices·9 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·0 affected·Sep 2, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Medical Devices·10 affected·Sep 2, 2021
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·31 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·846 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·138 affected·Sep 2, 2021
High RiskFDA
Biomerieux Sa
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Medical Devices·542 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, ST...
Surgical Devices·187 affected·Sep 2, 2021
High RiskFDA
Flower Orthopedics Corporation
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of...
Medical Implants·2 affected·Sep 1, 2021
High RiskFDA
Flower Orthopedics Corporation
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and...
Medical Implants·1 affected·Sep 1, 2021
High RiskFDA
The Baking Institute Baking Co.
Carrot cake (no brand), 6 inch and 8 inch sizes, on plastic base, with clear plastic dome. UPC code: 8 13749 01001 4 6-inch cake 8 5...
Bakery & Grains·159 affected·Aug 31, 2021
High RiskFDA
Centese Inc.
Thoraguard Chest Tube Kit, 20 Fr
Medical Devices·310 affected·Aug 31, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XX...
Medical Devices·109,787 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion...
Medical Devices·33,103 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Medical Devices·298 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion i...
Medical Devices·12 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); ...
Medical Devices·2,217 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIA...
Medical Devices·31,201 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Medical Devices·665 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06...
Medical Devices·41 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Nu...
Medical Devices·242,397 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force with software syngo.CT VB20 Model #10742326
Medical Devices·232 affected·Aug 30, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Injectable Drugs·28,658 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 ...
Oral Drugs·15,936 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine ...
Oral Drugs·4,752 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manuf...
Oral Drugs·31,248 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmin...
Oral Drugs·9,552 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Ph...
Oral Drugs·216,454 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine ...
Oral Drugs·1,800 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., U...
Oral Drugs·5,362 affected·Aug 27, 2021
High RiskFDA
Xstrahl Limited
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Medical Devices·120 affected·Aug 27, 2021
High RiskFDA
North American Rescue Llc.
10 ga ARS Decompression Needle, Part Number ZZ-0298
Medical Devices·51,424 affected·Aug 27, 2021
High RiskFDA
Ptw North America Corporation
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Medical Devices·1 affected·Aug 27, 2021
High RiskFDA
Avrio Health L.p
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP ...
Drugs·75,828 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Pioneer nuclear magnetic resonance imaging system
Medical Devices·5 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
Optima MR450w 1.5T nuclear magnetic resonance imaging system
Medical Devices·13 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Medical Devices·3 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Architect nuclear magnetic resonance imaging system
Medical Devices·2 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Medical Devices·6 affected·Aug 26, 2021