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High RiskFDA
Zimmer Biomet, Inc.
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Csl Behring Gmbh
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 ...
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Ti...
Medical Implants·1,631 affected·Jun 5, 2017
High RiskFDA
Angiodynamics, Inc.
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis...
Medical Devices·14,353 affected·Jun 5, 2017
High RiskFDA
Star Snacks Co., Llc.
Southern Grove Cashew Halves & Pieces with Sea Salt, Net Weight 8.0 oz. (227 grams)
Food·5,608 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·40 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device desi...
Medical Implants·443 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·373 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator ...
Medical Implants·9,529 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·54 affected·Jun 2, 2017
High RiskFDA
C.r. Bard, Inc.
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in t...
Surgical Devices·2,350 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator ...
Medical Implants·8,780 affected·Jun 2, 2017
High RiskFDA
L. Perrigo Company
Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2...
Oral Drugs·181,776 affected·Jun 1, 2017
High RiskFDA
Lucid Pharma Llc
Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottle...
Oral Drugs·44,168 affected·Jun 1, 2017
High RiskFDA
Xttrium Laboratories Inc
Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL ...
Oral Drugs·36,720 affected·Jun 1, 2017
High RiskFDA
American Pharmaceutical Ingredients Llc
Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged...
Drugs·23 affected·Jun 1, 2017
High RiskFDA
Medpark Pharmacy, Llc
methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
Injectable Drugs·1 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Arrow International Inc
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the cent...
Medical Devices·0 affected·Jun 1, 2017
High RiskFDA
Arrow International Inc
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the cent...
Medical Devices·0 affected·Jun 1, 2017
High RiskFDA
Master & Frank (pinghu) Co., Ltd.
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit w...
Surgical Devices·2,160 affected·Jun 1, 2017
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate c...
Surgical Devices·10 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Surgical Devices·32 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Arrow International Inc
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short o...
Surgical Devices·0 affected·Jun 1, 2017
High RiskFDA
Encore Medical, Lp
3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured ...
Medical Devices·9 affected·May 31, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnos...
Diagnostic Devices·98 affected·May 31, 2017
High RiskFDA
Becton Dickinson & Company
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/a...
Diabetes Devices·2,598,000 affected·May 31, 2017
High RiskFDA
Icu Medical, Inc.
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rota...
Surgical Devices·100 affected·May 30, 2017
High RiskFDA
Eos Imaging
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Nu...
Medical Devices·8 affected·May 30, 2017
High RiskFDA
Smith & Nephew, Inc.
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Medical Devices·36 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, ste...
Surgical Devices·1,100 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Prod...
Surgical Devices·120 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a...
Surgical Devices·50 affected·May 30, 2017
High RiskFDA
Hans Kissle Company, Llc
Whole Foods Cranberry Couscous- packaged in Clear plastic clamshell for 6oz, 14oz and 18oz, and white plastic pail for 10lb. UPC Codes: ...
Produce·580 affected·May 28, 2017
High RiskFDA
American Pharmaceutical Ingredients Llc
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC:...
Drugs·5,000 affected·May 26, 2017
High RiskFDA
Exactech, Inc.
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
Medical Devices·0 affected·May 25, 2017
High RiskFDA
Exactech, Inc.
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
Medical Devices·2,069 affected·May 25, 2017
High RiskFDA
Alcon Research, Ltd.
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alo...
Medical Devices·1,074 affected·May 25, 2017
High RiskFDA
Exactech, Inc.
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
Medical Devices·198 affected·May 25, 2017
High RiskFDA
Atrium Medical Corporation
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12...
Medical Implants·246 affected·May 25, 2017
High RiskFDA
Medical Components, Inc Dba Medcomp
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Pro...
Medical Implants·65 affected·May 25, 2017
High RiskFDA
Neurologica Corporation
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualifi...
Medical Devices·87 affected·May 24, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge OrthoPACS software.
Medical Devices·98 affected·May 24, 2017
High RiskFDA
Onkos Surgical, Inc.
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; RE...
Medical Devices·4 affected·May 23, 2017