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    Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.

    FDA Recall
    Terminated ·China Daheng Group Inc. # A9 Shangdi Xinxilu Haidian District Beijing China·Product code LYB·July 15, 2013

    The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.

    FDA Recall
    Terminated ·Synvasive Technology Inc·Product code HSD·March 14, 2013

    IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (5) ABSORBENT TOWELS 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD LIF (2) DRAPE SHEET 70" X 100" STD SMS LIF (1) MAYO TRAY LARGE (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF (1) BULB SYRINGE 60cc (2) BANDAGE ELASTIC 6" X 5"yds LIF (2) UTILITY BOWL 32oz (1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF (2) ABDOMINAL PAD 8" X 7 W (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' (2) GOWN IMPERVIOUS REINFORCED XL (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

    ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE WITHOUT VENT (2) LITE GLOVE (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) MAYO STAND COVER REINFORCED (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" (5) ABSORBENT TOWELS 15" X 20" (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV (4) DRAPE UTILITY (1) CAUTERY PENCIL ROCKER SWITCH (5) LAP SPONGES PREWASH XRD (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE (2) DRAPE SHEET 70" X 100" STD SMS (1) TIME OUT BEACON NON WOVEN (1) STAPLE SKIN WIDE 35 ST. (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) MAYO TRAY LARGE (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG (1) TOP DRAPE W/ADHES. 100" X 53" SMS (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP (2) BANDAGE ELASTIC 6" X 5"yds (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK (1) UTILITY BOWL 16oz (1) NEEDLE HYPODERMIC 18G X 1Y2 (2) UTILITY BOWL 32oz (2) BLADE SURGICAL# 10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

    ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TUBE SUCTION CONNECT W' X 12' UF (2) PAD ABDOMINAL 8" X 7.5" (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE W/0 VENT LIF (2) LITE GLOVE UF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (2) TABLE COVER REINFORCED 50" X 90" LIF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED LIF (1) SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F (5) TOWELS ABSORBENT 15" X 20" UF (1) STOKINETIE IMPERVIOUS 14" X 48" LIF (2) DRAPE SHEET 70" X 100" LIF (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) *GLOVE # 8 SURGEON NEUTRALON LATEX (1) SKIN STAPLE 35 WIDE UF (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX (1) TRAY MAYO LGE (1) GOWN SURG REINFORCED XL TOWEUWRAP (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF (2) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) BULB SYRINGE 60cc CLEAR (1) CAUTERY PENCYL ROCKER SWITCH UF (1) UTILITY BOWL 16oz LIF (1) BLADE SURGICAL# 20 STAINLESS STEEL (1) UTILITY BOWL QUART 32oz LIF (4) DRAPE UTILITY WITAPE UF (1) DRAPE INCISION 23" X 17" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

    MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHALLOW (12) COTION TIP APPLICATOR 6" WOOD (2) GLOVE SKY NITRILE PF BLUE MED (18) GAUZE SPONGES 4" X 4" 12PLY (1) SMALL DRAPE W/ADH APERTURE POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJK·May 20, 2014

    PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (10) GAUZE SPONGE 4" X 4" 16PLY (2) DRESSING NON ADH TELFA 4" X 3" (1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·May 20, 2014

    16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    FDA Recall
    Terminated ·Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen Germany·Product code HDA·December 28, 2018

    Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code HDA·March 13, 2019

    16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    FDA Recall
    Terminated ·Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen Germany·Product code HDA·December 28, 2018

    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code HDA·March 13, 2019

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013

    12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    FDA Recall
    Terminated ·Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen Germany·Product code HDA·December 28, 2018

    Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.

    FDA Recall
    Terminated ·Instrumentarium Dental, Inc.·Product code EDH·April 28, 2006

    12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    FDA Recall
    Terminated ·Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen Germany·Product code HDA·December 28, 2018

    Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6)BOX PST01134 LAP CHOLE KIT ST JOHN S (7)KIT00599 LAPARO GENERICO X1 (8)KIT00608 APENDICECTOMIA LAP X1 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA (10)KIT2951V CHOLECYSTECT BORNHOLM (11KIT2963 APPENDECTOMY KIT X1 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures. 1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223 (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223 (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO Lot Number: 0217118756 (2)BOX KIT00680 KIT COLECISTECTOMIA- 0217117865 0217118746 0217117863 0217117858 0217117864 0217117862 0217117861 0217117859 0217117857 0217117860 (3)BOX KIT00681 KIT APENDICECTOMIA 0217118750 0217118749 0217118748 0217118747 (4)BOX KIT00897 KIT COLON IZQUIERDO 0217134109 (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII 0217118761 (6)BOX PST01134 LAP CHOLE KIT ST JOHN S 0217119261, 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753, 0217130754 (8)KIT00608 APENDICECTOMIA LAP X1 0217132887 (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA 0217123007 (10)KIT2951V CHOLECYSTECT BORNHOLM 0217123010 (11KIT2963 APPENDECTOMY KIT X1 0217123009 (12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1 0217127223

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code HDA·March 13, 2019

    ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET SPLIT W/ADHES 1 08" X 77" LIF (1) COVER TABLE REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

    ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature reduction in patients where clinically indicated; Monitoring of patient temperature

    FDA Recall
    Terminated ·Life Recovery Systems HD, LLC·Product code NZE·October 21, 2011

    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 - 11ga 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); 1 - Towel; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***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