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High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 870228...
Inhaled / Nasal Drugs·4,990,860 affected·Oct 1, 2021
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 410...
Inhaled / Nasal Drugs·3,816,468 affected·Oct 1, 2021
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4...
Inhaled / Nasal Drugs·1,801,332 affected·Oct 1, 2021
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 200061...
Inhaled / Nasal Drugs·2,841,012 affected·Oct 1, 2021
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ir...
Inhaled / Nasal Drugs·592,416 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in ...
Medical Implants·26 affected·Oct 1, 2021
High RiskFDA
Limacorporate S.p.a
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Medical Devices·151 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in ...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Omnilife Science
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary tota...
Medical Implants·7 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th...
Medical Implants·9 affected·Oct 1, 2021
High RiskFDA
Craftmark Bakery, Llc
Chocolate Chip Cookie Dough packaged in 1 case, 6 bags/case, and 30 frozen pies of dough/bag. Labeling reads "Chocolate Chip Cookie Dough...
Bakery & Grains·4,632 affected·Sep 30, 2021
High RiskFDA
Lake Wolf Creamery
Lake Wolf Creamery Queso Oaxaca, ribbon cheese, refrigerated, vacuum packaged in flexible plastic packages, net wt. 3 lbs., 2 lbs., 1.5 l...
Dairy·40 affected·Sep 30, 2021
High RiskFDA
Lake Wolf Creamery
Lake Wolf Creamery Queso Fresco, crumbling fresh cheese, refrigerated, vacuum packaged in flexible plastic packages, net wt. 1.5 lbs. or ...
Dairy·18 affected·Sep 30, 2021
High RiskFDA
Beiersdorf Inc
Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 U...
Inhaled / Nasal Drugs·36,660 affected·Sep 30, 2021
High RiskFDA
Beiersdorf Inc
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 068...
Inhaled / Nasal Drugs·70,320 affected·Sep 30, 2021
High RiskFDA
Beiersdorf Inc
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 068...
Inhaled / Nasal Drugs·14,748 affected·Sep 30, 2021
High RiskFDA
Mentor Texas, Lp.
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. ...
Medical Implants·28,348 affected·Sep 30, 2021
High RiskFDA
Biomerieux, Inc.
API 50 CH, Model 50300
Medical Devices·1,382 affected·Sep 30, 2021
High RiskFDA
Coopersurgical, Inc.
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Surgical Devices·193 affected·Sep 29, 2021
High RiskFDA
Baxter Healthcare Corporation
Hemodialysis Delivery System, Software Version 2.x.
Medical Devices·4,248 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
Surgical Devices·75 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
Surgical Devices·154 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Surgical Devices·75 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
Surgical Devices·1,587 affected·Sep 29, 2021
High RiskFDA
Abbott Laboratories
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Medical Devices·20,994 affected·Sep 29, 2021
High RiskFDA
Revive Personal Products Company
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Product...
Drugs·258 affected·Sep 28, 2021
High RiskFDA
Cook Inc.
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorpor...
Medical Devices·48 affected·Sep 28, 2021
High RiskFDA
Elekta Solutions Ab
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552...
Medical Devices·2 affected·Sep 28, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM 1600 Analyzer, SMN 11066000
Medical Devices·1,733 affected·Sep 28, 2021
High RiskFDA
Amivas (us), Llc
Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials steri...
Injectable Drugs·292 affected·Sep 27, 2021
High RiskFDA
Strides Pharma Inc.
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengalur...
Oral Drugs·1,813 affected·Sep 27, 2021
High RiskFDA
Becton Dickinson & Company
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity t...
Medical Devices·8,000 affected·Sep 27, 2021
High RiskFDA
O&m Halyard Inc
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Medical Devices·2,928 affected·Sep 27, 2021
High RiskFDA
Medtronic Perfusion Systems
Cardioblate CryoFlex Surgical Ablation Console
Surgical Devices·7 affected·Sep 27, 2021
High RiskFDA
Pepsico Inc
Starbucks Doubleshot Espresso, Espresso & Light Cream, 6.5 FL OZ UPC 012000008801
Dairy·85,956 affected·Sep 26, 2021
High RiskFDA
Pepsico Inc
Starbucks Doubleshot Espresso, Espresso & Cream, 6.5 FL OZ UPC 012000001772
Dairy·85,956 affected·Sep 26, 2021
High RiskFDA
Pepsico Inc
Starbucks Doubleshot Espresso, Espresso & Salted Caramel Cream, 6.5 FL OZ UPC 012000007293
Dairy·85,956 affected·Sep 26, 2021
High RiskFDA
Suntree Snack Foods, Llc
Mountain Trail Mix, 44 oz. containing 22 packs , UPC 814314024153 (inner unit), 814314024160 (outer unit). 4 master bags/case.
Food·192 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Salted Cashews Halves & Pieces, 16 oz. , UPC 842379195303. 6 bags/case.
Food·140 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Mountain Trail Mix, 28 oz. , UPC 814314024146. 6 bags/case.
Food·160 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Roasted Salted Cashew Halves and Pieces, 32 oz. , UPC 072036734907. 6 jars/case.
Food·660 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Tropical Trail Mix, 15 oz. , UPC 072036735003. 8 bags/case.
Food·259 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Roasted Salted Cashew Halves and Pieces, 8 oz. , UPC 072036734891. 8 bags/case.
Food·960 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Lightly Salted Cashew Halves & Pieces, 16 oz., UPC 842379195341. 6 bags/case.
Food·700 affected·Sep 24, 2021
High RiskFDA
Fairlife Llc
FAIRLIFE MILK 8OZ / 6PK CHOCOLATE (multi-pack format of small single serve bottle); Date Code "MAY2722 FA"; Case UPC 008-11620-02207-1; U...
Dairy·1,137 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Salted Cashews Halves & Pieces, 40 oz. , UPC 842379195310. 6 bags/case.
Food·360 affected·Sep 24, 2021