Sheet1No.SourceManufacturerMedicalDevicePost DateCode1ECRIHummingbird MedicalABG-HM-1 Hummi Micro Draw Blood Transfer Devices14-Oct-15Catalog No. ABG-HM-1; Lot No. 151802MHRABlatchford Products LtdEndolite dynamic pylon top housing27-Sep-15Part # 539601 Male Shifting Top HousingPart # 539602 Female Shifting Top Housing3MHRAMedifab Medical FabricationShuttle Discovery27-Sep-15Model: Product code 2006-0010-000

Batch No:JS-06-14-DS-**,JS-15-14-DS-**,JS-18-14-DS-**,JS-23-14-DS-**,JS-45-14-DS-**,JS-46-14-DS-**,ML-8-15-DS-**,ML-13-15-DS-**,ML-16-15-DS4ECRISilimed IncVarious Medical Devices..28-Sep-15All Silimed Medical Devices including the following: (1) Silicone Implants for Plastic Surgery (e.g., breast implants, pectoral implants, gluteal implants, calf implants, hand surgery implants, tissue expanders, facial implants, nostril retainers, suspens5TGADickson & Dickson HealthcareOLS-500 & OLS-700 surgical lights18-Oct-15All OLS500/OLS700 lights manufactured and installed since January 2015 may be affected.6FDAConcentric Medical IncDistal Access Catheters13-Oct-15Lot no. 37603 Expiration date: September 20167NCARAlba BioscienceAnti-Leb ALBAclone18-Sep-15Lot : V158461Item number : Z2178ECRIPrism Medical LtdC136, CP136, and P136 Ceiling Lifts14-Oct-15C136CQ303140 through CQ304150CP136CP136-001 through CP136-0030, CPR0001 through CPR0230P136P303001 through P3049999BfArMAlba BioscienceAnti-Leb, clone LEB214-Oct-15lot OLebM091 with expiry date 2017-04based on the production lot V 15845910FDAViewray IncorporatedMRIdian ViewRay Radiation Therapy System13-Oct-15Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 10511TGAXcel Medical Solutions Pty LtdSuction Adapter Type A (Gauge)21-Sep-15Reference Number: X05101Lot Number: Z14120312BfArMAgency for Medical InnovationsMCS-Port Obturator / MCS500021-Sep-15MCS-Port Obturator / MCS5000, LOT 150318.13BfArMPyng Medical Corp.MATResponder Tourniquet21-Sep-15Lots : SL114711, SL115802, SL12136, SL121360, SL12131, SL121312, SL11317114FDAZien Medical Technologies, IncPenBlade Safety Scalpel24-Sep-15Models PB-M-10, PB-M-11P, PB-M-15

PenBlade Safety Scalpel, #10 blade, Code PBSS-M-10 PenBlade Safety Scalpel, #11P blade, Code PBSS-M-11P PenBlade Safety Scalpel, #15 blade, Code PBSS-M--1515FDAResource Optimization & Innovation LlcRegard 24-Sep-15- Item Number: 800208002; Sterile, CV0361B - CABG A&B.Product code : 025072B

- Item Number: 800628; Sterile, CV0805 - CABG BProduct code: 02373516BfArMAQUIS GmbHCutilyth sensitive Gel / Neutrosteralyth-Gel14-Oct-15Period of production 22.06.2015 to 18.08.201517SwissmedicBiocare Medical LlcSmooth Muscle Actin (SMA)08-Oct-15Model CME305A, CME305B, PME305AALot: see FSN18FDAAadco Medical Inc.AADCO Rayshield Frame Mounted Overhead X-Ray04-Feb-08Serial Numbers: 03028006 03028007 03028008 03029004 03029005 03029011 03037001 03050001 03050002 03050006 03055001 03055002 03057030 03063006 03071001 03073001 03078007 03083043 03086001 03087023 03097003 03098001 03099001 03101001 03104001 03113001 0311419ECRIAAT Alber Antriebstechnikmovilino Wheelchair Pushing and Braking Aids07-Dec-09N/A20ECRIABIOMED Europe GmbHAB Portable Drivers Used with Model AB5000 Circulatory Support Systems20-Jun-09AB Portable Drivers used with Model AB5000 Circulatory Support Systems21ECRIACE Medical Corp LtdAutoFuser Pain Pumps15-Jun-09Attached22FDAAcist Medical SystemsACIST Automated Manifold Kit07-Sep-09Lot numbers: 2968J 3088N 3168H 3178H 2968K 3088P 3168J 3308U 2968L 3088T 3168K 3468W23FDAAcumed LLCBiotrak Resorbable Fixation System25-Oct-0924ECRIAesculap IncS4 K-Wire Guiding Instruments02-Mar-0925ECRIAesculap IncKAIRISON Disposable Tubing15-Mar-0926ECRIAesculap IncModel GA411 microspeed uni Mobile Stands25-Mar-0927ECRIAesculap IncproCART Instrument Set Trephines25-Mar-0928ECRIAesculap IncCeramic Biolox Cup Inserts06-Apr-0929ECRIAesculap IncTargon PF Proximal Femoral Intramedullary Nail System Aiming Bows02-May-0930ECRIAesculap IncPremiCron Green and Safil Violet Sutures11-May-0931ECRIAesculap IncTargon PFT Proximal Femoral Intramedullary Nail Systems29-Nov-0932MHRAAesculap IncOrthopilot Active Transmitter Hip FS60516-Dec-0933ECRIAKS Aktuelle Krankenpflege SystemeFoldy and Torneo Patient Lifts*24-Jan-1034ECRIAllerderm/SmartPractice/Mekos Laboratories ApST.R.U.E. Test Epicutaneous Allergy Test Patch Systems*10-Jan-1035MHRAAngiotech / PBN Medicals Denmark A/SVarious pouches10-Oct-09Attached36MHRAARCOMA ABOrbixTop, ArcoSphere26-Sep-09Orbix Top Serial numbers:127, 130, 133, 147, 148, 149, 519ArcoSphere Serial numbers:121,126, 128, 129, 131, 140, 14537MHRAARCOMA ABArcoTable NT14-Oct-090055 ArcoTable NTInstallations without Collision protection installed38ECRIArcomedicalSyramed SP6000 Syringe Pumps20-Jan-0939FDAArgon Medical Devices IncArgon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire11-Feb-08Lot Number: 9950458740FDAArgon Medical Devices IncArgoguide Hydrophilic Wire03-Jun-09Attached41ECRIArthrex IncArthroscopic Pumps18-Apr-09Arthroscopic PumpsCatalog Nos.: AR-6400, AR-647542ECRIAssociates of Cape CodPyrotell Single Test Vial Limulus Amebocyte Lysate Reagents*21-Dec-0943ECRIB & H Surgical Instrument MakersElectrosurgical Forceps10-Jan-1044MHRABakare Bed LtdKleerside19-Dec-0945ECRIEBI LP Sub Biomet Inc.Phoenix and Uniflex Trauma Fixation System Screws23-Nov-0946NCARHuaian ?ngel Medical Instruments CO, LTD.., LtdPolyester green braid, Nylon (Polyamide) and black silk.25-Nov-0947ECRIJardine EnterprisesVarious Cribs14-Jan-09Attached48ECRIJoint Replacement InstrumentationBiPolar and Physiological Femoral Heads24-Jan-0949NCARKaneka CorporationFortis II ( Angioplasty Catheter)29-Mar-09Attached50MHRAKarma Mobility LimitedKarma 20 Self Propel Wheelchair08-Sep-0951NCARBARRX Medical IncElectrosurgical diathermy system handcontrolled13-Oct-08Lot/batch no.: F1012714, F10012715, F1012718, F10102721, F10102723, F1010272452NCARBARRX Medical IncGastrointestinal balloon catheter13-Oct-08Lot/batch no.: F101271953ECRIBerlin Heart AGEXCOR Paracorporeal Pulsatile Ventricular Assist Devices*10-Jan-1054MHRABiedermann Motech GmbH & Co. KGExt Tandem Connector16-Jan-1055FDABiomet IncBiomet Vanguard Width Checker & Knee Instrumentation08-Apr-08Lot Number-212910.56FDABiomet IncBiomet Optigun Cement Gun, Ratchet, non-sterile21-Jan-08All units including lots 429900, 642100 and 647700.57FDABiomet IncBiomet CC Cruciate Tibial Tray11-Feb-08Lot Number: 448530.58ECRIBiomet Inc85 mm 7 Holes 1/3 Tubular Bone Plates24-Jan-09Item/Part No. 2122-085-007S; Lot No. 161291159MHRABiomet IncKent Hip Twist Drills09-Sep-09Items numbers 31-401478 & 31-40147960MHRABiomet IncVanguard Lock-On Femoral Impactor19-Dec-09(Part Number #32-486206) Lot code #424590, #ZB070903 and #28071127updated lot.Lots 122890, 296900, 433560, 433570, 433580, 433590, 433600, 646610 and 943990.61MHRABiomet Inc19mm diameter Oxford Revision Stems27-Dec-09Item Numbers #650-0735, 650-0736,6 50-0737,6 50-0755,650-0756 and 650-0757All Lots up to #I40953562FDABiomet MicrofixationLactosorb Trauma Plating System11-Oct-08Part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. Lot numbers: 898240, 898330, 898250, 898350, 898320, 951140, 868920, and 97881063MHRABrandon MedicalOndal Acrobat 2000 spring arms07-Oct-0964FDABreg Inc, An Orthofix CompanyPolar Care Kodiak12-Sep-0965NCARCaesarea Medical Electronics LtdInfusion pump, general purpose29-Jun-09T34 syringe driver Code: 100-100PSM66ECRIC P MedicalATRIASEPT II Atrial Septal Defect and Patent*20-Jan-1067FDACardinal HealthPulmonetic Systems LTV 800 Ventilator20-Aug-08Serial numbers: D01002, D01004, D01005, D01006, D01007, D01011, D01013, D01014, D01015, D01016, D01017, D01018, D01019, D01024, D01025, D01026, D01027, D01031, D01033, D01034, D01035, D01037, D01038, D01040, D01043, D01044, D01045, D01046, D01048, D01049,68FDACardinal HealthEsteem Blue with Neu Thera Surgeons Glove, size 627-Jun-09lot numbers TS0409472 through TS09020495.69ECRICardinal HealthTeleflex Medical Sheridan Preformed Cuffed Nasal Tracheal Tubes25-Jul-09Attached70ECRICardinal HealthGF Health Products John Bunn Jackson Stainless Steel Tracheostomy Tubes23-Nov-09Attached71ECRICardinal HealthRed Precision Dynamics Securline Blood Band Plus Wristbands23-Nov-09Catalog No. 2406-16-PDB; Lot/Work Order No. 102931372NCARChangzhou kanghui Medical Innovation Co LtdScrews, Bone25-Nov-09All lot number.73FDAChattem IncIcy Hot Heat Therapy , Air Activated Heat Patch15-Mar-08All Lots74FDACincinnati Sub-Zero Products IncWarmAir 13501-Nov-0975ECRICincinnati Sub-Zero Products IncSterile TempPad Cold Therapy Pads*21-Dec-0976FDACincinnati Sub-Zero Products IncTempPad Cold Therapy Pad AND WARM AIR WARMING UNIT06-Feb-1077FDACook Inc.Peel-Away Introducer set, Catheter introducer, sterile03-May-08Lot Number: F2118728.78ECRICory Brothers LtdProcedurePak Kits containing 12 mm Cory Bros Trocars07-Dec-09Product Nos.: 97009925-03, Lot Nos.: 0745-4607, 0746-7461, 0748-0606, 0804-4490

Product Nos.: 97009925-04, Lot Nos.: 0816-1630, 0819-7967, 0822-1106, 0824-5978, 09093232, 09107506,09225050, 09236963, 09241583, 0927960279NCARCryoCath Technologies Inc.Catheter Introducer, FlexCath Steerable Sheath - 2FC1201-Jun-08All lots80FDACTS, Inc. dba Guidant Cardiac SurgeryVASOVIEW 4 Endoscopic Vessel Harvesting System30-Dec-08model numbers VH-10242, lot numbers 7100172 to 8081371, and VH-10243, lot numbers 7100171 to 8081271.81FDACurlin Medical LlcModel 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump18-Oct-08Model Number: 340-1001, Serial Numbers for all affected units: 100074 to 21045882FDACurlin Medical LlcModel 4000 Plus Ambulatory Infusion Pump18-Oct-08Model Number: 350-1001, Serial Numbers for all affected units: 100074 to 21045883FDACustom Ultrasonics, IncSystem 83 Plus Washer-Disinfector, Endoscope use15-Mar-08All Serial Numbers84ECRIData Innovations North AmericaInstrument Managers19-Apr-0985FDADell medical systems groupDell CTM and DCTM ceiling t