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High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-0...
Medical Devices·1,244 affected·Nov 9, 2017
High RiskFDA
Rocky's Historic Eastern Market
DARK CHOCOLATE CHERRY, 16 oz., 25 pound bulk case
Snacks & Candy·447 affected·Nov 8, 2017
High RiskFDA
Detroit City Nut, Llc
Dark Chocolate Peanuts, 16 oz.
Snacks & Candy·29 affected·Nov 8, 2017
High RiskFDA
Detroit City Nut, Llc
Dark Chocolate Raisins, 16 oz.
Snacks & Candy·55 affected·Nov 8, 2017
High RiskFDA
Rocky's Historic Eastern Market
DARK CHOCOLATE CRANBERRY, 16 oz., 25 pound bulk case
Snacks & Candy·433 affected·Nov 8, 2017
High RiskFDA
Detroit City Nut, Llc
Dark Chocolate Almonds, 10 oz.
Snacks & Candy·92 affected·Nov 8, 2017
High RiskFDA
Nestle Usa
Nestle HOT POCKETS¿ FOUR CHEESE PIZZA SNACK BITES in clear plastic bags.
Dairy·4,200 affected·Nov 8, 2017
High RiskFDA
L. Perrigo Company
Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo,...
Oral Drugs·19,944 affected·Nov 8, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Healthcare Brilliance iCT computed tomography x-ray system
Medical Devices·702 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Diagnostic Devices·1,385 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Diagnostic Devices·134 affected·Nov 8, 2017
High RiskFDA
Med Tec Inc
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1...
Medical Devices·5 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
Diagnostic Devices·238 affected·Nov 8, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Medical Devices·134 affected·Nov 8, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
No Sugar Added Pumpkin Pie Baked whole pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Food·1 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Apple Streusel Pie - Baked whole/half pies and Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) ...
Frozen Food·55 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Pecan Pie Baked whole pies, Baked 1/2 pies & frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 78...
Frozen Food·38 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Lemon Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 78...
Frozen Food·15 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Apple Top Pie Baked whole pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Food·3 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Sugar Cream Pie Baked whole/half pies & frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Dairy·8 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Strawberry Pie Baked whole/half pies & frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Produce·15 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Toll House Pie Baked whole/half pies & frozen pies, Stevens Bakery & Orchard ,7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Frozen Food·16 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Blackberry Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard 7344 Thackery Road, Springfield, Ohio 45502, (937...
Produce·25 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
No Sugar Added Apple Pie Baked 1/2 pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Food·4 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Peach Pie Baked whole pies & Baked 1/2 pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Food·15 affected·Nov 7, 2017
High RiskFDA
Stevens Family Bakery & Orchard Llc
Cherry Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 7...
Frozen Food·36 affected·Nov 7, 2017
High RiskFDA
Dominguez Family Enterprises, Inc
Juanita's Brand OJOS Mexican Pastry. Product are pink balls of cake rolled in coconut packed in a flex plastic bag of varying weight. 6 ...
Bakery & Grains·516 affected·Nov 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body ...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body o...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Pacific Rim Distribution Inc.
Bean Boy Coffee Dark Chocolate Covered Espresso Beans
Snacks & Candy·1,064 affected·Nov 6, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·2,660 affected·Nov 6, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·708 affected·Nov 6, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the p...
Surgical Devices·25,400 affected·Nov 6, 2017
High RiskFDA
Boston Scientific Corporation
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascu...
Medical Implants·22,916 affected·Nov 6, 2017
High RiskFDA
Southmedic, Inc.
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping...
Surgical Devices·3,300 affected·Nov 6, 2017
High RiskFDA
Gourmet Nut, Inc.
GourmetNut DARK CHOCOLATE COVERED ALMONDS NET WT 7oz (198g); UPC: 708747152203
Snacks & Candy·5,640 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC...
Topical Drugs·0 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC...
Topical Drugs·0 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 6980...
Drugs·0 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 698...
Topical Drugs·0 affected·Nov 3, 2017
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