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High RiskFDA
Encore Medical, Lp
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Medical Devices·10 affected·Jun 24, 2015
High RiskFDA
Pages Produce Company Inc.
La Mexicana Spinach Dip Net Wt. 14oz. clear, plastic cup Product is packaged in plastic white container.
Produce·12,432 affected·Jun 23, 2015
High RiskFDA
O-two Medical Technologies, Inc.
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: T...
Respiratory Devices·4,382 affected·Jun 23, 2015
High RiskFDA
Solutions Rx Pharmacy
c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SO...
Oral Drugs·11,712 affected·Jun 22, 2015
High RiskFDA
Nobel Biocare Usa Llc
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was a...
Medical Implants·149 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Draeger Medical, Inc.
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and rec...
Medical Devices·373 affected·Jun 22, 2015
High RiskFDA
Ford Gum & Machine Company Inc
Project 7 CARAMEL APPLE Sugar Free Gum, approximately 32 lbs. -- Manufactured by: Ford Gum and Machine Company, 18 Newton Ave., Akron, Ne...
Produce·6,496 affected·Jun 19, 2015
High RiskFDA
Project 7
Sour Caramel Apple Chewing, net wt .53 oz, Gum UPC 844911 002919. Sour Caramel Apple chewing gum tablet packed in 12ct metalized PET P...
Food·88,206 affected·Jun 19, 2015
High RiskFDA
Coopersurgical, Inc.
Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilator...
Surgical Devices·40 affected·Jun 19, 2015
High RiskFDA
Medtronic Minimed Inc.
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-17...
Medical Devices·1,936 affected·Jun 19, 2015
High RiskFDA
Atrium Medical Corporation
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Surgical Devices·62 affected·Jun 19, 2015
High RiskFDA
Argon Medical Devices, Inc
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBM...
Medical Devices·10,290 affected·Jun 18, 2015
High RiskFDA
Argon Medical Devices, Inc
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; B...
Medical Devices·6,390 affected·Jun 18, 2015
High RiskFDA
Allergan Inc
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implan...
Medical Implants·167 affected·Jun 18, 2015
High RiskFDA
Allergan Inc
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation...
Medical Implants·23 affected·Jun 18, 2015
High RiskFDA
Zimmer, Inc.
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Medical Devices·8 affected·Jun 17, 2015
High RiskFDA
Agilent Technologies, Inc.
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A40015...
Medical Devices·364 affected·Jun 17, 2015
High RiskFDA
B. Braun Interventional Systems
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable ...
Medical Implants·11 affected·Jun 16, 2015
High RiskFDA
Symmetry Surgical, Inc.
SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws for...
Surgical Devices·2,708 affected·Jun 16, 2015
High RiskFDA
Liberty Drug & Surgical
Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main ...
Drugs·3 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham...
Injectable Drugs·6 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·5 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·2 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatha...
Injectable Drugs·15 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·6 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195...
Injectable Drugs·6 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 0...
Injectable Drugs·5 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box ...
Injectable Drugs·2 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·112 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box...
Injectable Drugs·2 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·88 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chath...
Injectable Drugs·85 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, ...
Injectable Drugs·6 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box ...
Injectable Drugs·2 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO B...
Injectable Drugs·4 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·4 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO ...
Injectable Drugs·2 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·1 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·5 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·58 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Ophthalmic Drugs·1 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·22 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·30 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main...
Injectable Drugs·4 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·1,755 affected·Jun 15, 2015