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High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Medical Devices·1,086 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Medical Devices·763 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Medical Devices·259 affected·Jun 2, 2014
High RiskFDA
Caromont Farm
Chevre (Pasteurized Goats Milk Cheese) Four oz. cups Fresh Chevre / Bulk Chevre - One, two, and five pound sizes
Dairy·0 affected·May 30, 2014
High RiskFDA
Caromont Farm
Plank Road Round (Pasteurized Cows Milk Cheese).4 oz. plastic sealed with protective band.
Dairy·0 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, ...
Drugs·30 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Oral Drugs·850 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield...
Drugs·184 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Drugs·6,000 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19...
Drugs·8 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol D...
Drugs·55 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·15 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·65 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·122 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·71 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·83 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·2 affected·May 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Diagnostic Devices·34,283 affected·May 30, 2014
High RiskFDA
Carestream Health Inc.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently inst...
Diagnostic Devices·100 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·2 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·156 affected·May 30, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutica...
Oral Drugs·8,472 affected·May 29, 2014
High RiskFDA
B. Braun Medical, Inc.
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Medical Devices·10,835 affected·May 29, 2014
High RiskFDA
Mckesson Medical Immaging
Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive ...
Medical Devices·659 affected·May 29, 2014
High RiskFDA
Kerr Corporation
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a...
Medical Devices·2,030 affected·May 29, 2014
High RiskFDA
Elekta, Inc.
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 3...
Medical Devices·224 affected·May 29, 2014
High RiskFDA
Shape Medical Systems, Inc
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-40...
Medical Devices·800 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous eval...
Medical Devices·164 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evalua...
Medical Devices·147 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous ev...
Medical Devices·34 affected·May 28, 2014
High RiskFDA
Dot Foods Inc.
Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, ...
Food·720 affected·May 27, 2014
High RiskFDA
Interbake Foods Llc
Mrs. Fields Milk Chocolate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 individually wrapped 1 oz cookies. 12 cartons in a ...
Dairy·16 affected·May 24, 2014
High RiskFDA
Brunkow Cheese Of Wisconsin, Inc.
Fayette Creamery Jalapeno Pepper Raw Milk Cheddar Cold Pack Cheese, Net Wt. 8 oz (226g), UPC 09513-00008
Dairy·4,160 affected·May 23, 2014
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratori...
Oral Drugs·13,560 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarn...
Medical Devices·7,460 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: ...
Medical Devices·7,190 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula ...
Medical Devices·6,720 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Ven...
Medical Devices·34,470 affected·May 23, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module,...
Respiratory Devices·4,961 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusio...
Medical Devices·120 affected·May 23, 2014
High RiskFDA
Elekta, Inc.
MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among h...
Medical Devices·723 affected·May 23, 2014
High RiskFDA
Zimmer, Inc.
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femora...
Medical Implants·315 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion o...
Medical Devices·3,040 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: ...
Medical Devices·2,290 affected·May 23, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; R...
Medical Devices·20,507 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicate...
Medical Devices·135,340 affected·May 23, 2014
High RiskFDA
Aidarex Pharmaceuticals Llc
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories...
Oral Drugs·531 affected·May 22, 2014
High RiskFDA
Sandoz, Inc
Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, ...
Oral Drugs·22,818 affected·May 22, 2014