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CriticalFDA
Allergan Plc
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-36...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Inf...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation...
Medical Implants·4,026,287 affected·Jul 24, 2019
High RiskFDA
Lemaitre Vascular, Inc.
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm...
Surgical Devices·62 affected·Jul 24, 2019
High RiskFDA
Wilson-cook Medical Inc.
Hemospray Endoscopic Hemostat
Medical Devices·160 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Pr...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: B...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require perio...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:1...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set S...
Medical Implants·4,026,287 affected·Jul 24, 2019
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Man...
Topical Drugs·0 affected·Jul 23, 2019
High RiskFDA
Omnilife Science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H...
Medical Implants·22 affected·Jul 23, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Medical Devices·27,676 affected·Jul 23, 2019
High RiskFDA
Instrumentation Laboratory Co.
ROTEM ex-tem Canada Part No: 503-05-CA
Medical Devices·44 affected·Jul 23, 2019
High RiskFDA
Instrumentation Laboratory Co.
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Medical Devices·722 affected·Jul 23, 2019
High RiskFDA
Instrumentation Laboratory Co.
ROTEM ex-tem; US Part No: 503-05-US
Medical Devices·364 affected·Jul 23, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies...
Diagnostic Devices·139 affected·Jul 23, 2019
High RiskFDA
Aggredyne, Inc.
AggreGuide A-100 Instrument
Medical Devices·47 affected·Jul 23, 2019
High RiskFDA
Omnilife Science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Produ...
Medical Implants·6 affected·Jul 23, 2019
High RiskFDA
Wise Pharmacy
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Injectable Drugs·97 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Drugs·1 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Injectable Drugs·32 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, ...
Injectable Drugs·14 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 8...
Injectable Drugs·44 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 8...
Injectable Drugs·84 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Injectable Drugs·8 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Litt...
Injectable Drugs·27 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO...
Inhaled / Nasal Drugs·1 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Li...
Drugs·1 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Injectable Drugs·4 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Diagnostic Devices·12,796 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Diagnostic Devices·10,928 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Diagnostic Devices·3,627 affected·Jul 22, 2019
High RiskFDA
Elevation Foods
Fresket egg salad packaged in 32oz plastic cup with lid, 2 cups per case, refrigerated
Produce·294 affected·Jul 19, 2019
High RiskFDA
Elevation Foods
Fresket Tuna Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
Seafood·13 affected·Jul 19, 2019
High RiskFDA
Elevation Foods
Fresket Thai Lobster Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
Seafood·208 affected·Jul 19, 2019
CriticalFDA
Elevation Foods
Archer Farms egg salad packaged in 12oz plastic cup with lid, 6 cups per case, refrigerated
Produce·572 affected·Jul 19, 2019
CriticalFDA
The Cookie Dough Cafe
The Cookie Dough Cafe - Chocolate chip chilled gourmet edible cookie dough; 1.6 oz bars, packaged in plastic wrappers, 16 bars per wholes...
Bakery & Grains·16,080 affected·Jul 19, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. B...
Oral Drugs·11,832 affected·Jul 19, 2019
High RiskFDA
Dercher Enterprises, Inc., Dba Gordon Laboratories
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon L...
Drugs·277 affected·Jul 19, 2019
High RiskFDA
Ascend Laboratories Llc
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufacture...
Oral Drugs·5,472 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-...
Medical Devices·7,168 affected·Jul 19, 2019
High RiskFDA
Nobel Biocare Usa Llc
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Medical Implants·221 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000...
Medical Devices·19,351 affected·Jul 19, 2019
High RiskFDA
Stryker Corporation
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Medical Devices·87 affected·Jul 19, 2019
High RiskFDA
Coltene /whaledent Ag
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Medical Devices·20 affected·Jul 19, 2019