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High RiskFDA
Varian Medical Systems, Inc.
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Numb...
Medical Devices·151 affected·Aug 12, 2019
High RiskFDA
Vitony Bakery, Inc.
Vitony Bakery, Brazo Gitano Guayaba Queso (Guava- Cheese Cake Roll); Peso Neto 12 ONZ. (340 G)
Dairy·340 affected·Aug 9, 2019
High RiskFDA
Vitony Bakery, Inc.
Vitony Bakery, Bizcocho de Guayaba y Coco (Guava-Coconut Pudding Cake); Peso Neto 14 ONZ. (397 G)
Bakery & Grains·1,041 affected·Aug 9, 2019
High RiskFDA
Tri-union Frozen Products, Inc.
Cracked Pepper Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (70 g) pouch: Shelf Stable UPC 0 48000 01179 ...
Meat & Poultry·576 affected·Aug 9, 2019
High RiskFDA
Vitony Bakery, Inc.
Vitony Bakery, Bizcocho de Queso y Guayaba (Cheese-Guava Pudding Cake); Peso Neto 14 ONZ. (397 G)
Dairy·2,354 affected·Aug 9, 2019
High RiskFDA
Tri-union Frozen Products, Inc.
Lemon Chive Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (70 g) pouch: Shelf Stable UPC 0 48000 01179 4 a...
Meat & Poultry·576 affected·Aug 9, 2019
High RiskFDA
Whole Foods Market
365 Organic Maple & Brown Sugar Pecan Instant Oatmeal 2.3 oz (65 g) microwaveable cups that are sold individually
Food·972 affected·Aug 9, 2019
High RiskFDA
Ridge Properties, Llc
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-...
Topical Drugs·109 affected·Aug 9, 2019
High RiskFDA
Ridge Properties, Llc
Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (...
Topical Drugs·109 affected·Aug 9, 2019
High RiskFDA
Ridge Properties, Llc
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), ...
Topical Drugs·383 affected·Aug 9, 2019
High RiskFDA
Ridge Properties, Llc
Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69...
Topical Drugs·104 affected·Aug 9, 2019
High RiskFDA
Ridge Properties, Llc
Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-07...
Topical Drugs·136 affected·Aug 9, 2019
High RiskFDA
American Health Packaging
Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American He...
Oral Drugs·457 affected·Aug 9, 2019
High RiskFDA
Ridge Properties, Llc
Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 6...
Topical Drugs·383 affected·Aug 9, 2019
High RiskFDA
Randox Laboratories Ltd.
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are ...
Diagnostic Devices·100 affected·Aug 9, 2019
High RiskFDA
Nobel Biocare Usa Llc
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - P...
Medical Implants·227 affected·Aug 9, 2019
High RiskFDA
Nobel Biocare Usa Llc
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 ...
Medical Implants·239 affected·Aug 9, 2019
High RiskFDA
Nobel Biocare Usa Llc
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-...
Medical Implants·238 affected·Aug 9, 2019
High RiskFDA
Nobel Biocare Usa Llc
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catal...
Medical Implants·478 affected·Aug 9, 2019
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Impl...
Medical Implants·23 affected·Aug 9, 2019
High RiskFDA
Medline Industries Inc
Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Medical Devices·11,962 affected·Aug 9, 2019
High RiskFDA
Keto Farms Llc
Keto Farms Keto Snack Mix - Tomato Pepperjack Fruit & Cheese Mix with Sprouted Pecans & Walnuts; Net Wt. 95 g (3.34 oz. Ingredient...
Dairy·2,762 affected·Aug 8, 2019
High RiskFDA
Keto Farms Llc
Keto Farms Keto Snack Mix - Raspberry Gouda Fruit & Cheese Mix with Sprouted Almonds & Walnuts; Net Wt. 95 g (3.34 oz. Ingredients...
Dairy·2,762 affected·Aug 8, 2019
High RiskFDA
First Start Holdings Inc
Nosh Organic Fruit & Protein Soft Oat Bar; Apple, Sweet Potato & Cinnamon. 6 - 0.74 oz. (21 g) bars per box. Net Wt. 4.44 oz. 126g) I...
Produce·11,996 affected·Aug 8, 2019
High RiskFDA
First Start Holdings Inc
Nosh Organic Fruit & Protein Soft Oat Bar; Blueberry & Banana. 6 - 0.74 oz. (21 g) bars per box. Net Wt. 4.44 oz. 126g) Ingredients: ...
Beverages·13,526 affected·Aug 8, 2019
High RiskFDA
Keto Farms Llc
Keto Farms Keto Snack Mix - Strawberry Gouda; Fruit & Cheese Mix with Sprouted Pecans & Almonds; Net Wt. 95 g (3.34 oz.) Ingredients...
Dairy·2,762 affected·Aug 8, 2019
High RiskFDA
Alkermes Inc
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2)...
Injectable Drugs·6,514 affected·Aug 8, 2019
High RiskFDA
Radiometer Medical Aps
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE syste...
Medical Devices·947 affected·Aug 8, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Medical Devices·23 affected·Aug 8, 2019
High RiskFDA
First Rate Plantation
Sweet Basil Farm Hawaii
Food·190 affected·Aug 7, 2019
High RiskFDA
Intersurgical Inc
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
Medical Devices·19,200 affected·Aug 7, 2019
High RiskFDA
Intersurgical Inc
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
Medical Devices·115,200 affected·Aug 7, 2019
High RiskFDA
Intersurgical Inc
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
Medical Devices·46,450 affected·Aug 7, 2019
High RiskFDA
Aesculap Implant Systems Llc
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic proc...
Medical Devices·3 affected·Aug 7, 2019
High RiskFDA
Integra Lifesciences Corp.
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #...
Medical Devices·237 affected·Aug 7, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Cardiac Devices·22,244 affected·Aug 6, 2019
High RiskFDA
Arrow International Inc
8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACT...
Surgical Devices·520 affected·Aug 6, 2019
High RiskFDA
Clinical Innovations, Llc
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Medical Devices·2,340 affected·Aug 6, 2019
High RiskFDA
Arrow International Inc
Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous ...
Surgical Devices·231 affected·Aug 6, 2019
High RiskFDA
Martin's Famous Pastry Shoppe, Inc.
Martin's 8 Sandwich POTATO ROLLS NET WT. 15oz (425 GRAMS) plastic bag MARTIN'S PASTRY SHOPPE, INC. 1000 Potato Roll Lane Chambersburg, PA...
Bakery & Grains·383 affected·Aug 5, 2019
High RiskFDA
Belfonte Ice Cream & Dairy Foods Co
FROZEN VAN YOG, in 3 gallon cardboard buckets
Frozen Food·1,246 affected·Aug 5, 2019
High RiskFDA
Remedyrepack Inc.
Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original ...
Oral Drugs·480 affected·Aug 5, 2019
High RiskFDA
Pregel America, Inc.
PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of f...
Beverages·179 affected·Aug 2, 2019
High RiskFDA
Milkweed & Monarch, Llc
Ginger Spice, 1 oz (28.4 g), 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM
Beverages·5 affected·Aug 1, 2019
High RiskFDA
Bimbo Bakeries Usa Inc.
Entenmann's Little Bites Soft Baked Cookies (5 pack Mini Chocolate Chip variety) Net Weight of 5ct box 6.88oz. 5 pouches per package, pa...
Bakery & Grains·160,000 affected·Aug 1, 2019
High RiskFDA
Milkweed & Monarch, Llc
Honey Lavender, 1 oz, 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM
Beverages·21 affected·Aug 1, 2019
High RiskFDA
Milkweed & Monarch, Llc
Sandia Rose, 1 oz (28.4 g), 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM
Beverages·11 affected·Aug 1, 2019
High RiskFDA
Becton Dickinson & Company
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Medical Devices·700 affected·Aug 1, 2019