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High RiskFDA
The Compounder
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue U...
Oral Drugs·180 affected·Mar 10, 2015
High RiskFDA
The Compounder
ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounde...
Topical Drugs·6 affected·Mar 10, 2015
High RiskFDA
The Compounder
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandroster...
Topical Drugs·12 affected·Mar 10, 2015
High RiskFDA
The Compounder
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Tra...
Topical Drugs·1 affected·Mar 10, 2015
High RiskFDA
The Compounder
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream...
Topical Drugs·9 affected·Mar 10, 2015
High RiskFDA
Freedom Pharmaceuticals Inc
Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 5...
Drugs·20 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are i...
Surgical Devices·30,796 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to ev...
Surgical Devices·9,168 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended...
Surgical Devices·3,180 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX ...
Surgical Devices·10 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be wor...
Surgical Devices·11 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be wo...
Surgical Devices·153 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX I...
Surgical Devices·303 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgic...
Surgical Devices·38 affected·Mar 10, 2015
High RiskFDA
Us Endoscopy Group Inc
Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic pro...
Medical Devices·1,695 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accesso...
Surgical Devices·5,889 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intende...
Surgical Devices·32,496 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: ...
Surgical Devices·270 affected·Mar 10, 2015
High RiskFDA
Cuisine Innovations Llc Dba Bon Appetizers, Llc
Guiltless Gourmet Southwestern Veggie Burger 2.5oz 48 pieces Distributed by: Cuisine Innovations, LLC. 1920 Swarthmore Avenue, Lakewood...
Food·90 affected·Mar 9, 2015
High RiskFDA
Summit Import Corporation
Yang Sheng Preserved Egg (Long-Lansing Duck Egg), each box contains 6 preserved eggs, each box weighs about 12 ounce (340g), Manufacturer...
Food·68 affected·Mar 9, 2015
High RiskFDA
Cuisine Innovations Llc Dba Bon Appetizers, Llc
Black Bean Burger 4.5 oz 40 pieces Net Wt. 11.25 lbs. (5.10 kg)Manufactured by: Cuisine Innovations, LLC Lakewood, NJ 08701 USA UPC 00030...
Food·7,052 affected·Mar 9, 2015
High RiskFDA
Pharmatech Llc
Rugby Poly Vitamin Liquid with Iron, 50 ml
Supplements·52,554 affected·Mar 9, 2015
High RiskFDA
Pharmatech Llc
Rugby Poly Vitamin Liquid, 50ml
Supplements·59,930 affected·Mar 9, 2015
High RiskFDA
Cuisine Innovations Llc Dba Bon Appetizers, Llc
Southwestern 4oz Veggie Burger 36 count Net Wt 9 lb. (4.08 kg) Distributed by Performance Food Group Richmond, VA 23238 UPC 00806795422276
Food·1,864 affected·Mar 9, 2015
High RiskFDA
Walong Marketing, Inc.
Wu Fu Yuan New Sago Taro, Net Wt: 8.8oz. (250g), Manufactured by: Shanghai Yuan Zhen Food Co., Ltd, 4968-2, UPC 6927055989033
Food·905 affected·Mar 9, 2015
High RiskFDA
Navinta Llc
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sand...
Injectable Drugs·14,628 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Applian...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the...
Medical Devices·260 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Medical Devices·38 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
Medical Devices·32 affected·Mar 9, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T...
Medical Devices·9,369 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal re...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x10mm, Article No. 36700.
Medical Devices·1,456 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
Medical Devices·23 affected·Mar 9, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD)...
Diagnostic Devices·132 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended t...
Medical Implants·74 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Medical Devices·2 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x8mm, Article No. 36704.
Medical Devices·102 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x13mm, Article No. 36702.
Medical Devices·594 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the sk...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x11.5mm, Article No. 36701.
Medical Devices·1,155 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended ...
Medical Implants·23 affected·Mar 9, 2015
High RiskFDA
Ge Healthcare
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Medical Devices·797 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occ...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used ...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
Medical Devices·53 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x10mm, Article No. 36705.
Medical Devices·1,077 affected·Mar 9, 2015