BEUDAMED
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    Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·October 7, 2015

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Recall
    Terminated ·STERILMED, INC.·Product code KCY·November 13, 2015

    Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.

    FDA Recall
    Terminated ·STERILMED, INC.·Product code KCY·August 24, 2015

    Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329 The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is at risk for deep vein thrombosis or could otherwise benefit from enhanced blood flow and circulation and/or a reduction in post operative pain and swelling.

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

    EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation.

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

    Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision cutting or dissecting and cauterizing soft tissue.

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

    Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

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

    Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of the femoral artery or vein after cauterization.

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

    Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment.

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

    Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired.

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

    Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.

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

    Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324

    FDA Enforcement
    Class II ·Terminated·Sterilmed, Inc.·October 17, 2018

    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·October 15, 2014

    Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.

    FDA Enforcement
    Class II ·Terminated·Sterilmed Inc·July 12, 2017

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

    FDA Enforcement
    Class I ·Terminated·Sterilmed Inc·January 3, 2018

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016

    External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86 Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation.

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

    Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

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

    Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599 The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination.

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