Skip to main content
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC...
Inhaled / Nasal Drugs·0 affected·Nov 3, 2017
High RiskFDA
Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ...
Surgical Devices·2 affected·Nov 3, 2017
High RiskFDA
Alden Optical
NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear fo...
Medical Devices·33 affected·Nov 3, 2017
High RiskFDA
Madison Polymeric Engineering
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instru...
Surgical Devices·285 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Medical Devices·15 affected·Nov 3, 2017
High RiskFDA
Stryker Neurovascular
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Mi...
Surgical Devices·1 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except tha...
Medical Devices·1 affected·Nov 3, 2017
High RiskFDA
Beaver-visitec International Inc.
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usag...
Surgical Devices·45 affected·Nov 3, 2017
High RiskFDA
Brainlab Ag
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 T...
Medical Devices·28 affected·Nov 3, 2017
High RiskFDA
Beaver-visitec International Inc.
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: ...
Surgical Devices·572,490 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indic...
Medical Devices·4 affected·Nov 3, 2017
High RiskFDA
Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS ...
Surgical Devices·2 affected·Nov 3, 2017
High RiskFDA
Medtronic Inc.
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptoma...
Medical Implants·21 affected·Nov 3, 2017
High RiskFDA
Handicare Usa Inc
Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.
Medical Devices·716 affected·Nov 3, 2017
High RiskFDA
Volcano Corporation
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 4...
Medical Devices·1,166 affected·Nov 3, 2017
High RiskFDA
Alden Optical
NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for ...
Medical Devices·3 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·5 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·56 affected·Nov 3, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Pumpkin Spice Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Krem...
Bakery & Grains·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Mini Crullers, Net Wt. 10 oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winst...
Food·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Original Glazed Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Sa...
Food·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Blueberry Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Kreme Do...
Bakery & Grains·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Cake, Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem...
Bakery & Grains·4,041 affected·Nov 2, 2017
High RiskFDA
Kellbran Candies And Snacks Inc
DRIZZLED VANILLA POPCORN Net Wt. 3 oz (84.9g) Ingredients: Popcorn, corn syrup, sugar, lecithin***ALLERGY INFO: Manufactured in a facilit...
Dairy·520 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Mini Crullers, Krispy Juniors, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Wins...
Food·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Original Glazed Doughnuts, Net Wt. 9.4oz (half dozen) and Net Wt. 18.7oz (one dozen), Manufactured under the auth...
Food·4,041 affected·Nov 2, 2017
High RiskFDA
Epigenomics Ag
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer,...
Medical Devices·200 affected·Nov 2, 2017
High RiskFDA
Pro-med Instruments Gmbh
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY...
Medical Devices·1,142 affected·Nov 2, 2017
High RiskFDA
Aurora Products, Inc.
Dark Chocolate Almonds packaged in: 4 oz. Plastic Pouch, 9 oz. Plastic Cup, 9 oz. Stand Up Plastic Pouch, 12 oz. Square Plastic Tub,...
Snacks & Candy·39,724 affected·Nov 1, 2017
High RiskFDA
Aurora Products, Inc.
Dark Chocolate Turbinado Almonds w/ Sea Salt packaged in : 7 oz. Plastic Cup Packaged under the following: Aurora Brand and Store Br...
Snacks & Candy·1,128 affected·Nov 1, 2017
High RiskFDA
Aurora Products, Inc.
Dark Chocolate Coffee beans packaged in Bulk 4 oz. Plastic Pouch 8.25 oz. Plastic Pouch 8.25 oz. Plastic Cup 17 oz. Family Size Pl...
Snacks & Candy·15,040 affected·Nov 1, 2017
High RiskFDA
Natures Touch Frozen Foods Llc
Nature's Touch US frozen Organic Whole Beans, 10-oz., UPC code 8 7366800141
Frozen Food·13,619 affected·Nov 1, 2017
High RiskFDA
Dutch Valley Food Distributors Inc.
Dark Chocolate Cashew, Net 11 oz., Contains Cashew and Soy, Distributed By: Dutch Valley Food Distributors, Inc., Myerstown, PA 17067; UP...
Snacks & Candy·19 affected·Nov 1, 2017
High RiskFDA
Aurora Products, Inc.
Aurora Brand Dark Chocolate Cherries packaged in: 8.5 oz. Plastic Cup 11 oz. Square Plastic Tub
Snacks & Candy·468 affected·Nov 1, 2017
High RiskFDA
Steve's Gourmet Confections
Dark Chocolate Almonds, 6 oz. and Bulk
Snacks & Candy·25 affected·Nov 1, 2017
High RiskFDA
Steve's Gourmet Confections
Dark Chocolate Banana Chips, 12 oz.
Snacks & Candy·726 affected·Nov 1, 2017
High RiskFDA
Aurora Products, Inc.
Dark Chocolate Cranberries packaged in: Bulk 3.5 oz. Plastic Cup 4.75 oz. Plastic Pouch 9 oz. Plastic Cup 9 oz. Plastic Pouch 1...
Snacks & Candy·35,100 affected·Nov 1, 2017
High RiskFDA
Givaudan Flavours Corp
NATURAL MIREPOIX FLAVOR 181.4 kgs/drum Ingredients: Carrot Juice, Celery Juice Concentrate, Dextrose, Autolyzed Yeast Extract, Onion Juic...
Beverages·50 affected·Nov 1, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Diagnostic Devices·2 affected·Nov 1, 2017
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Prot...
Medical Devices·3 affected·Nov 1, 2017
High RiskFDA
John Zidian Co
Gia Russa Spaghetti Dinner Sauce TRADITIONAL NET WT. 1 Lb. 8 oz (24 oz) 680 grams INGREDIENTS: Tomato Puree***Canola Oil, Sugar, Modified...
Produce·362 affected·Oct 31, 2017
High RiskFDA
Ruckers Makin Batch Candies
dark chocolate peanuts, 8.5 oz.
Snacks & Candy·1,944 affected·Oct 31, 2017
High RiskFDA
Ruckers Makin Batch Candies
The Toothsome Chocolate Emporium Dark Chocolate Peanuts. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Choc...
Snacks & Candy·1,416 affected·Oct 31, 2017
High RiskFDA
Shoreline Fruit, Llc
Shoreline Fruit Dark Choc Covered Montmorency Cherries packaged in 25-pound corrugated box
Produce·9,182 affected·Oct 31, 2017
High RiskFDA
Whole Alternatives Llc
Dark Chocolate Covered Almonds 9 oz clam shell & 25 lb box Ingredients: Dark Chocolate (Sugar, chocolate Liquor, Cocoa Butter, Chocolate ...
Dairy·369 affected·Oct 31, 2017
High RiskFDA
Shoreline Fruit, Llc
Dried Dark Chocolate Covered Cherries, The products are packaged in 25-pound corrugated boxes and 6 oz. and 24 oz. stand-up pouch packaging.
Snacks & Candy·9,182 affected·Oct 31, 2017
High RiskFDA
Ruckers Makin Batch Candies
The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans. The affected product is packaged in 8 oz. clear bag within a gold Toothsome...
Snacks & Candy·1,800 affected·Oct 31, 2017
High RiskFDA
Ruckers Makin Batch Candies
The Toothsome Chocolate Emporium Dark Chocolate Cranberries. The affected product is packaged in 8 oz. clear bag within a gold Toothsome ...
Snacks & Candy·912 affected·Oct 31, 2017