Skip to main content
High RiskFDA
Agfa Healthcare Corp.
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to docume...
Medical Devices·10 affected·Dec 22, 2016
High RiskFDA
Mako Surgical Corporation
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Medical Devices·777 affected·Dec 22, 2016
High RiskFDA
Rich Products Corp
Signature SELECT Vanilla Ice Cream & White Cake ICE CREAM CAKE , NET WT 4 LB 13 OZ, KEEP FROZEN, UPC 021130 114641, Product Code 06620 ---
Dairy·6,632 affected·Dec 21, 2016
High RiskFDA
Rich Products Corp
RICH'S 1/4 Sheet White Cake with Vanilla Ice Cream Cake, KEEP FROZEN, UNIT NET WT: 60 OZ (3 LB 12 OZ), COUNT: 4 x 1/4 SHEET CAKES, NET CA...
Dairy·6,632 affected·Dec 21, 2016
High RiskFDA
Capitol City Specialties Company
the Peanut Principle, Dashing Thru the Dough, Gourmet Chocolate Chip Cookie Dough Peanut Butter, NET WT 16oz, UPC 609207898788
Dairy·900 affected·Dec 21, 2016
High RiskFDA
Rich Products Corp
Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy vanilla ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 ...
Dairy·6,632 affected·Dec 21, 2016
High RiskFDA
Teva Pharmaceuticals Usa
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, S...
Oral Drugs·133,601 affected·Dec 21, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in ...
Diagnostic Devices·1,379 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K@home Series : Hemodialysis System
Medical Devices·1,400 affected·Dec 21, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·279 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K2 Series : Hemodialysis System
Medical Devices·60,151 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008T Series Hemodialysis System
Medical Devices·65,361 affected·Dec 21, 2016
High RiskFDA
Agfa Healthcare Corp.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Medical Devices·221 affected·Dec 21, 2016
High RiskFDA
Herr Foods, Inc.
Smoked Chipotle Flavored Kettle Cooked Potato Chips 2.625 oz and 8.0 oz
Snacks & Candy·0 affected·Dec 20, 2016
High RiskFDA
Hungry Heart Bakery
Walnut Chocolate Chunk Cookies, Hungry Heart brand, packaged in a clear Cello bags, heat sealed. 6 units per bag. Net wt. 9.75 oz. (276g)
Bakery & Grains·12 affected·Dec 20, 2016
High RiskFDA
Herr Foods, Inc.
Dried Smoke Chipotle Flavored Kettle Cooked Potato Chips 2.0 oz.
Snacks & Candy·0 affected·Dec 20, 2016
High RiskFDA
Hungry Heart Bakery
Peanut Butter Cookies, Hungry Heart brand. Product is packaged in a clear Cello bag, heat sealed. 6 units per bag. Net wt. 6.5 oz. (184g)
Dairy·12 affected·Dec 20, 2016
High RiskFDA
Hungry Heart Bakery
Cracker Jax, Hungry Heart brand, packaged in a clear Cello bag, heat sealed. Net wt. 8 oz. (227g).
Bakery & Grains·6 affected·Dec 20, 2016
High RiskFDA
Hungry Heart Bakery
Chocolate Chip Sea Salt Cookies, Hungry Heart brand. Product is packaged in a clear cello bags, heat sealed. 1 unit per bag. Net wt. 2.7...
Bakery & Grains·15 affected·Dec 20, 2016
High RiskFDA
Mylan Llc.
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan ...
Oral Drugs·574 affected·Dec 20, 2016
High RiskFDA
Mylan Llc.
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
Oral Drugs·588 affected·Dec 20, 2016
High RiskFDA
Accord Healthcare, Inc.
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Oral Drugs·12,896 affected·Dec 20, 2016
High RiskFDA
Mylan Llc.
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan ...
Oral Drugs·300 affected·Dec 20, 2016
High RiskFDA
Mylan Llc.
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan ...
Oral Drugs·746 affected·Dec 20, 2016
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App
Diabetes Devices·27,243 affected·Dec 20, 2016
High RiskFDA
Becton Dickinson & Company
Eclipse Hypodermic Needle
Medical Devices·263 affected·Dec 20, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concen...
Diagnostic Devices·659,957 affected·Dec 20, 2016
High RiskFDA
Portland Specialty Baking Llc
ALN UNICED 1/4 Sheet Split Layer White Cake, Item 00886, three stacked cake layers with plastic liner in between layers are packaged in a...
Bakery & Grains·3,314 affected·Dec 19, 2016
High RiskFDA
Pinnacle Foods
Buffalo Blue Kettle Cooked Potato Chips 8 oz (227g)
Snacks & Candy·17 affected·Dec 19, 2016
High RiskFDA
Small Fry Inc.
Route 11 Sour Cream & Chive Potato Chips2 oz bag (30/cs) Route 11 Sour Cream & Chive Potato Chips6 oz bag (12/cs)
Dairy·2 affected·Dec 19, 2016
High RiskFDA
The Henry Gonsalves Co.
Gonsalves Sugar Coated Almonds, Net Wt. 12 oz. Distributed by The Gonsalves Company, Smithfield, RI 02917 UPC number 20539-64550
Food·75 affected·Dec 19, 2016
High RiskFDA
Beckman Coulter Inc.
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Medical Devices·1,282 affected·Dec 19, 2016
High RiskFDA
Bard Access Systems
SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 S...
Medical Implants·8,000 affected·Dec 19, 2016
High RiskFDA
In2bones, Sas
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating ...
Medical Devices·19 affected·Dec 19, 2016
High RiskFDA
In2bones, Sas
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is int...
Medical Devices·40 affected·Dec 19, 2016
High RiskFDA
Zimmer Biomet, Inc.
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners ...
Medical Devices·36 affected·Dec 19, 2016
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during dia...
Cardiac Devices·0 affected·Dec 19, 2016
High RiskFDA
In2bones, Sas
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticu...
Medical Devices·26 affected·Dec 19, 2016
High RiskFDA
Bard Access Systems
MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. Th...
Medical Implants·7,200 affected·Dec 19, 2016
High RiskFDA
Zimmer Biomet, Inc.
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Medical Devices·19 affected·Dec 19, 2016
High RiskFDA
Ge Oec Medical Systems, Inc
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluo...
Surgical Devices·0 affected·Dec 19, 2016
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Medical Devices·4,657 affected·Dec 19, 2016
High RiskFDA
House-autry Mills, Inc
House-Autry Buttermilk Biscuit Mix Tote, Net Wt., 8 oz. (227 g.), UPC Code 0 73484 15500 9,
Dairy·1,217 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
Buddy's Bar-B-Q Hushpuppy Mix, Net Wt., 5 lb bags, UPC Code 0 73484 22156 2,
Food·658 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
Po Folks Cornbread Mix, Net Wt., 5 lb bags, UPC Code 0 73484 22509 2
Bakery & Grains·299 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
Roy Roger's Pancake Mix, Net Wt., 2 lb. 8 oz. bags, UPC Code 0 73484 22724 0
Bakery & Grains·141 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
House-Autry Cheese Biscuit Mix, Net Wt., 8 oz. (227 g.), UPC Code 0 73484 15510 8,
Dairy·987 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
House Autry, stone Ground Buttermilk Corn Bread Mix, Net wt. 8 oz. boxes, UPC Code 0 73484 15512 2,
Dairy·1,456 affected·Dec 18, 2016