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High RiskFDA
Medtech Products, Inc.
Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoli...
Ophthalmic Drugs·25,992 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes M...
Ophthalmic Drugs·1,836 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNES...
Ophthalmic Drugs·793,872 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distri...
Ophthalmic Drugs·1,030,128 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (...
Ophthalmic Drugs·124,038 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM ...
Ophthalmic Drugs·17,316 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (G...
Ophthalmic Drugs·1,752 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. ...
Ophthalmic Drugs·1,621,200 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78...
Ophthalmic Drugs·6,661,188 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Me...
Ophthalmic Drugs·1,872,984 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF ...
Ophthalmic Drugs·314,112 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) b...
Ophthalmic Drugs·927,108 affected·Jul 26, 2019
High RiskFDA
Medtech Products, Inc.
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (...
Ophthalmic Drugs·66,168 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and acce...
Surgical Devices·52 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and ac...
Surgical Devices·123 affected·Jul 26, 2019
High RiskFDA
Becton Dickinson & Co.
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Medical Devices·9 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perf...
Surgical Devices·4 affected·Jul 26, 2019
High RiskFDA
Becton Dickinson & Co.
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Medical Devices·4 affected·Jul 26, 2019
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mo...
Medical Devices·59 affected·Jul 26, 2019
High RiskFDA
Herbs Unlimited D/b/a Rock Garden South
Fresh basil with Rock Garden brand label. Basil was packed in 1 lb. plastic bags and in 0.75 oz. clear plastic clamshell containers.
Food·1,320 affected·Jul 25, 2019
High RiskFDA
Hyde & Hyde Inc
Organic Asian Sesame Ginger packets, 2.95 oz
Food·9,000 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a ...
Surgical Devices·35 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system ...
Surgical Devices·2,248 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system ...
Surgical Devices·251 affected·Jul 25, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOM...
Medical Devices·2,867 affected·Jul 25, 2019
High RiskFDA
Neurologica Corporation
WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01...
Diagnostic Devices·5,088 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a ...
Surgical Devices·76 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF sys...
Surgical Devices·1,533 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EP...
Surgical Devices·110 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF sy...
Surgical Devices·259 affected·Jul 25, 2019
High RiskFDA
Neurologica Corporation
HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00...
Diagnostic Devices·3,582 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is ...
Surgical Devices·476 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system...
Surgical Devices·53 affected·Jul 25, 2019
High RiskFDA
Ch Guenther & Sons, Inc
Winco Foods, Taco Seasoning Mild, Net Wt. 1.25 OZ, Distributed by Winco Foods, LLC, Boise, ID, UPC 0 70552 90126 1
Food·646 affected·Jul 24, 2019
High RiskFDA
Ch Guenther & Sons, Inc
Great Value Mild Taco Seasoning, Net Wt. 1 OZ, Distributed by Wal-Mart Stores, Inc. Bentonville, AR. UPC 0 78742 24572v0
Food·6,770 affected·Jul 24, 2019
High RiskFDA
Ch Guenther & Sons, Inc
HEB Taco Seasoning Mix 25% Less Sodium Net Wt. 1.25 OZ, H-E-B San Antonio TX UPC 0 41220 79609 0
Food·1,261 affected·Jul 24, 2019
High RiskFDA
Siga Logistics S De Rl De Cv
SIGA Fresh Basil, 1 lb bag, 10 plastic bags (1 lb bag) per carton
Food·15,000 affected·Jul 24, 2019
High RiskFDA
Meninno Brothers Gourmet Foods
Hannaford brand 20 oz. traditional quiche w/tomatoes, cheese and basil in flexible plastic with round top and bottom.
Dairy·405 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drugs·1 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman A...
Injectable Drugs·191 affected·Jul 24, 2019
High RiskFDA
Alvogen, Inc
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Di...
Drugs·4,272 affected·Jul 24, 2019
High RiskFDA
Alvogen, Inc
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 ...
Oral Drugs·2,784 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drugs·1 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drugs·1 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drugs·1 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drugs·7 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, C...
Drugs·7 affected·Jul 24, 2019
High RiskFDA
Colonia Care Pharmacy
C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, ...
Ophthalmic Drugs·1 affected·Jul 24, 2019