BEUDAMED
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    ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.

    FDA Recall
    Terminated ·Suros Surgical Systems Inc.·Product code KNW·May 25, 2006

    HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GJS·April 9, 2013

    Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc·February 20, 2013

    Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·November 26, 2014

    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

    FDA Enforcement
    Class I ·Terminated·Fisher & Paykel Healthcare, Ltd.·January 9, 2013

    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·March 29, 2017

    Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code GAD·August 8, 2008

    Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 " Safety Needle; 1 21ga x 1-1/2" Safety Needle; 1 25ga x 5/8" Safety Needle; 1 - 10cc Syringe L/L; 2 - 20cc Syringe L/L; 3 - 4" x 4" Sponges in stacks of 5; 2 - 3" x 3" Sponges in stacks of 5; 1 - CSR Wrap; 2 - Fenestrated Drape; 1 - 5" Hemostat Straight Mosquito; 1 - #11 Retractable Scalpel; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - Probe Guide; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Obturator; 2 - Petri Dish***Catalog Number: CB00541TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 - 2"x3" ADH Dressing; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Obturator; 1 - Male Luer Cap; 1 - Probe Guide; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - CSR Wrap ***Catalog Number: BMET0804TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***TLok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen Label; 1 - Stirring Rod; 1 - 8ga x 4 Bone Marrow Needed J Type; 1 16ga x 2.688 Bone Marrow Needle I Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides - Frosted end; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 - Obturator; 1- Male Luer Cap; 1 T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 - CSR Wrap***Catalog Number: BMT0804TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Specimen Label; 1 - Stirring Rod; 1 8ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Glass Slide Poly Bag***Catalog Number: BMT0804ATL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 -Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2" x 3" ADH Dressing; 1 -Towel; 1 - 15ga x 4" Bone Marrow Needle "I" Type; 1 - 2% Lidocaine (10mL); 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - T_Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0356TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom Bone Marrow Tray for University of CA, Davis*** 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 8ga x 4" Bone Marrow Needed "J" Type; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 - T- Lok Extraction Cannula; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - Probe Guide; 1 - Obturator; 2 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 2 - 4" x 4" Sponges in stacks of 5; 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap***Catalog Number: CB0140TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code DQY·December 18, 2009

    AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MAE·September 6, 2005

    AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MAE·September 6, 2005