Medical device recalls reported in 2016

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Reported	Recall	Class	Product	Firm
2016-11-02	Z-0302-2017	Class II	ex-TEM Assay for ROTEM delta Thromboelastometry System	TEM Systems Inc
2016-11-02	Z-0303-2017	Class II	ReTurn 7500/7500 Aid	Handicare USA, Inc.
2016-11-02	Z-0304-2017	Class II	4205 Journey Rolling Walker Product Usage: used to assist people in…	Nova Ortho-Med Inc
2016-11-02	Z-0305-2017	Class II	Symbiq One Channel Infuser	Hospira Inc.
2016-11-02	Z-0306-2017	Class II	Symbiq Two Channel Infuser	Hospira Inc.
2016-11-02	Z-0311-2017	Class III	PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec…	Becton Dickinson & Co.
2016-11-02	Z-0312-2017	Class III	PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec &#38	Becton Dickinson & Co.
2016-11-02	Z-0313-2017	Class III	VITROS Immunodiagnostic Products HBsAg Controls	Ortho-Clinical Diagnostics
2016-11-02	Z-0314-2017	Class II	SimpliRED D-Dimer	BBI SOLUTIONS OEM LTD
2016-11-02	Z-0315-2017	Class II	da Vinci¿ Xi" Surgical System	Intuitive Surgical, Inc.
2016-11-02	Z-0316-2017	Class II	Safil QUI + UNDY 5/0	Aesculap Implant Systems LLC
2016-11-02	Z-0317-2017	Class II	Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling…	Zimmer Biomet, Inc.
2016-11-02	Z-0318-2017	Class II	Pentax Video Gastroscope is intended to be used with a Pentax video…	Pentax of America Inc
2016-11-02	Z-0319-2017	Class II	IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay	Siemens Healthcare Diagnostics, Inc.
2016-11-02	Z-0320-2017	Class II	IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay	Siemens Healthcare Diagnostics, Inc.
2016-10-26	Z-0004-2017	Class I	Skintact Electrodes for Defibrillation	Leonhard Lang Medizintechnik GmbH
2016-10-26	Z-0005-2017	Class I	HeartWare Ventricular Assist System Controller Product Usage: For use…	Heartware, Inc.
2016-10-26	Z-0044-2017	Class I	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised…	Teleflex Medical
2016-10-26	Z-0053-2017	Class I	Vascular Solutions Twin-Pass Dual Access Catheter	Vascular Solutions, Inc.
2016-10-26	Z-0054-2017	Class I	Vascular Solutions Twin-Pass RX Dual Access Catheter	Vascular Solutions, Inc.
2016-10-26	Z-0055-2017	Class I	Vascular Solutions Twin-Pass	Vascular Solutions, Inc.
2016-10-26	Z-0087-2017	Class II	Uniflex Humeral Nail: 467265 G-PIN 2	Zimmer Biomet, Inc.
2016-10-26	Z-0088-2017	Class II	SDMS	SenTec AG
2016-10-26	Z-0089-2017	Class II	VITROS Chemistry Products GLU Slides	Ortho-Clinical Diagnostics
2016-10-26	Z-0090-2017	Class II	VITROS Chemistry Products LAC Slides	Ortho-Clinical Diagnostics
2016-10-26	Z-0091-2017	Class II	VITROS Chemistry Products TRIG Slides	Ortho-Clinical Diagnostics
2016-10-26	Z-0092-2017	Class II	VITROS Chemistry Products URIC Slides	Ortho-Clinical Diagnostics
2016-10-26	Z-0093-2017	Class II	LipiFlow thermal Pulsation System	Tearscience, Inc
2016-10-26	Z-0111-2017	Class II	Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful…	Zimmer Biomet, Inc.
2016-10-26	Z-0112-2017	Class II	Sagittal Blade 18	Stryker Instruments Div. of Stryker Corporation
2016-10-26	Z-0113-2017	Class II	Cytoplast Titanium-Reinforced Posterior Singles Membrane A…	Osteogenics Biomedical, Inc.
2016-10-26	Z-0118-2017	Class II	CADstream software Product Usage: CADstream is an image processing…	Merge Healthcare, Inc.
2016-10-26	Z-0119-2017	Class II	25 gauge VersaVit 2	Synergetics Inc
2016-10-26	Z-0120-2017	Class II	25 gauge VersaVit 2	Synergetics Inc
2016-10-26	Z-0121-2017	Class II	25 gauge VersaVit 2	Synergetics Inc
2016-10-26	Z-0122-2017	Class II	25 gauge VersaVit 2	Synergetics Inc
2016-10-26	Z-0123-2017	Class II	Randox Lipase	Randox Laboratories Ltd.
2016-10-26	Z-0124-2017	Class II	Calix P PEEK Lumbar System	X Spine Systems Inc
2016-10-26	Z-0125-2017	Class II	Calix P PEEK Lumbar System	X Spine Systems Inc
2016-10-26	Z-0126-2017	Class II	Calix T PEEK Lumbar System	X Spine Systems Inc
2016-10-26	Z-0127-2017	Class II	Calix T PEEK Lumbar System	X Spine Systems Inc
2016-10-26	Z-0128-2017	Class II	CD79b PE	Becton, Dickinson and Company, BD Biosciences
2016-10-26	Z-0129-2017	Class II	CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for…	ConMed Corporation
2016-10-26	Z-0130-2017	Class II	CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for…	ConMed Corporation
2016-10-26	Z-0131-2017	Class II	CORE¿ Suction Irrigation Handpiece Y-Tubing set	ConMed Corporation
2016-10-26	Z-0132-2017	Class II	CORE¿ Suction Irrigation Handpiece without Probe for Single Solution…	ConMed Corporation
2016-10-26	Z-0133-2017	Class II	CORE¿ Suction Irrigation Handpiece without Probe for Single Solution…	ConMed Corporation
2016-10-26	Z-0134-2017	Class II	CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe	ConMed Corporation
2016-10-26	Z-0135-2017	Class II	CORE¿ Trumpet Handpiece only	ConMed Corporation
2016-10-26	Z-0136-2017	Class II	Agee-WristJack¿ Fracture Reduction System	Hand Biomechanics Lab Inc
2016-10-26	Z-0137-2017	Class II	CADstream software	Merge Healthcare, Inc.
2016-10-26	Z-0138-2017	Class II	OER-Pro Endoscope Reprocessor	Olympus Corporation of the Americas
2016-10-26	Z-0139-2017	Class II	Abdominoplasty Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0140-2017	Class II	Abdominoplasty Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0141-2017	Class II	Anterior Cervical Fusion Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0142-2017	Class II	Arthroscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0143-2017	Class II	Augmentation Mammoplasty Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0144-2017	Class II	Basic Extended Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0145-2017	Class II	Basic Face Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0146-2017	Class II	Basic Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0147-2017	Class II	Basic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0148-2017	Class II	Basic Setup Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0149-2017	Class II	Basic Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0150-2017	Class II	Basin Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0151-2017	Class II	Bayview Abdominoplasty Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0152-2017	Class II	Bayview Breast Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0153-2017	Class II	Bleph Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0154-2017	Class II	Body Contour Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0155-2017	Class II	Breast Augmentation Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0156-2017	Class II	Breast Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0157-2017	Class II	Brow Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0158-2017	Class II	C-Birth Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0159-2017	Class II	C-Section Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0160-2017	Class II	C-Tray Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0161-2017	Class II	Cardiac Cath Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0162-2017	Class II	Cath Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0163-2017	Class II	Custom Arterial Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0164-2017	Class II	Custom Breast Augmentation Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0165-2017	Class II	Custom Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0166-2017	Class II	Custom Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0167-2017	Class II	Custom Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0168-2017	Class II	Custom Venous Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0169-2017	Class II	D & C Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0170-2017	Class II	D&C/Cysto Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0171-2017	Class II	D&C/GYN/Hysteroscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0172-2017	Class II	DND Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0173-2017	Class II	Dr Bragg Vein Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0174-2017	Class II	Dr Mullins Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0175-2017	Class II	Dr	Windstone Medical Packaging, Inc.
2016-10-26	Z-0176-2017	Class II	Dr	Windstone Medical Packaging, Inc.
2016-10-26	Z-0177-2017	Class II	Dr	Windstone Medical Packaging, Inc.
2016-10-26	Z-0178-2017	Class II	Dr	Windstone Medical Packaging, Inc.
2016-10-26	Z-0179-2017	Class II	Dr	Windstone Medical Packaging, Inc.
2016-10-26	Z-0180-2017	Class II	Endoscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0181-2017	Class II	ENT Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0182-2017	Class II	ENT Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0183-2017	Class II	Extremity Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0184-2017	Class II	Extremity Pack-N Brunswick	Windstone Medical Packaging, Inc.
2016-10-26	Z-0185-2017	Class II	Extremity Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0186-2017	Class II	Eye Plastic Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0187-2017	Class II	Eye Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0188-2017	Class II	Face Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0189-2017	Class II	Facial Plastic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0190-2017	Class II	Facial Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0191-2017	Class II	Foot Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0192-2017	Class II	General Male Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0193-2017	Class II	General Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0194-2017	Class II	General Pack I	Windstone Medical Packaging, Inc.
2016-10-26	Z-0195-2017	Class II	General Pack II	Windstone Medical Packaging, Inc.
2016-10-26	Z-0196-2017	Class II	General Plastic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0197-2017	Class II	General Plastics Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0198-2017	Class II	General Surgery Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0199-2017	Class II	GLBSC Minor Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0200-2017	Class II	GYN Lap Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0201-2017	Class II	GYN Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0202-2017	Class II	GYN-Laparoscopy Tray AMS1196	Windstone Medical Packaging, Inc.
2016-10-26	Z-0203-2017	Class II	Hall SAP	Windstone Medical Packaging, Inc.
2016-10-26	Z-0204-2017	Class II	Hand Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0205-2017	Class II	Hand Tray PSS2365	Windstone Medical Packaging, Inc.
2016-10-26	Z-0206-2017	Class II	Head and Neck Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0207-2017	Class II	Head Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0208-2017	Class II	Hernia Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0209-2017	Class II	HSG Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0210-2017	Class II	Hystero Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0211-2017	Class II	Knee Arthroscopy Pack AMS2610	Windstone Medical Packaging, Inc.
2016-10-26	Z-0212-2017	Class II	Knee Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0213-2017	Class II	Knee Scope Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0214-2017	Class II	Laminectomy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0215-2017	Class II	Lap Band Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0216-2017	Class II	Lap Gallbladder Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0217-2017	Class II	Lap/Hyst Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0218-2017	Class II	Lap/Pelviscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0219-2017	Class II	Laparoscopic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0220-2017	Class II	Laparoscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0221-2017	Class II	Laparotomy Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0222-2017	Class II	Laparotomy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0223-2017	Class II	Laparotomy Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0224-2017	Class II	Lipo Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0225-2017	Class II	Liposuction Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0226-2017	Class II	Lithotomy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0227-2017	Class II	Local Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0228-2017	Class II	Lower Extremity Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0229-2017	Class II	Lumbar Laminectomy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0230-2017	Class II	Major Breast Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0231-2017	Class II	Major General Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0232-2017	Class II	Major Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0233-2017	Class II	Major Laparotomy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0234-2017	Class II	Major Lithotomy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0235-2017	Class II	Major Ortho Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0236-2017	Class II	Major Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0237-2017	Class II	Mammoplasty Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0238-2017	Class II	Minor Arthroscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0239-2017	Class II	Minor Lap Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0240-2017	Class II	Minor Lithotomy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0241-2017	Class II	Minor Ortho Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0242-2017	Class II	Minor Pack AMS1374	Windstone Medical Packaging, Inc.
2016-10-26	Z-0243-2017	Class II	Minor Tray AMS2685 convenience custom kits used for general surgery…	Windstone Medical Packaging, Inc.
2016-10-26	Z-0244-2017	Class II	Minor/General/Ortho Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0245-2017	Class II	Mok Eye Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0246-2017	Class II	Morris Hysto Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0247-2017	Class II	Morris Lap Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0248-2017	Class II	Nasal Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0249-2017	Class II	Newport Coast Basic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0250-2017	Class II	OB/GYN Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0251-2017	Class II	Ocular Plastic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0252-2017	Class II	Open Procedure Pack II	Windstone Medical Packaging, Inc.
2016-10-26	Z-0253-2017	Class II	Ortho Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0254-2017	Class II	Ortho Minor Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0255-2017	Class II	Ortho Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0256-2017	Class II	Pacemaker Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0257-2017	Class II	Pelviscopy/Laparoscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0258-2017	Class II	Percutaneous Entry Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0259-2017	Class II	Peri GYN	Windstone Medical Packaging, Inc.
2016-10-26	Z-0260-2017	Class II	Peri Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0261-2017	Class II	Plastic General Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0262-2017	Class II	Plastic Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0263-2017	Class II	Plastic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0264-2017	Class II	Podiatry Kit PSS1040	Windstone Medical Packaging, Inc.
2016-10-26	Z-0265-2017	Class II	Podiatry Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0266-2017	Class II	Robotic Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0267-2017	Class II	Set Up Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0268-2017	Class II	Set-Up Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0269-2017	Class II	Shoulder Arthroscopy Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0270-2017	Class II	Shoulder Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0271-2017	Class II	Spine Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0272-2017	Class II	Student Pack-NS	Windstone Medical Packaging, Inc.
2016-10-26	Z-0273-2017	Class II	Surgical Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0274-2017	Class II	Taymour GYN Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0275-2017	Class II	Total Hip Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0276-2017	Class II	Total Joint Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0277-2017	Class II	Total Knee Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0278-2017	Class II	Transvaginal Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0279-2017	Class II	Universal Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0280-2017	Class II	Upper Extremity Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0281-2017	Class II	Upper Torso Tray	Windstone Medical Packaging, Inc.
2016-10-26	Z-0282-2017	Class II	Vaginal Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0283-2017	Class II	Vein Kit	Windstone Medical Packaging, Inc.
2016-10-26	Z-0284-2017	Class II	Virginia Custom Pack	Windstone Medical Packaging, Inc.
2016-10-26	Z-0285-2017	Class II	Dr	Windstone Medical Packaging, Inc.
2016-10-26	Z-0286-2017	Class II	Laparoscopy Kit	Windstone Medical Packaging, Inc.

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