BEUDAMED
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    Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·August 2, 2007

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code IYE·October 24, 2013

    Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures

    FDA Recall
    Terminated ·Maquet Inc.·Product code NCP·May 29, 2012

    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

    FDA Recall
    Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code PFT·April 26, 2018

    Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.

    FDA Recall
    Terminated ·C P Medical, Inc.·Product code NEW·September 22, 2014

    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code GCP·April 19, 2017

    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code GCP·August 18, 2017

    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code FCP·February 11, 2015

    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GCP·November 11, 2025

    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GCP·September 13, 2024

    Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GCP·September 13, 2024

    PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

    FDA Recall
    Open, Classified ·CP Medical Inc·Product code GAM·February 2, 2017

    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

    FDA Recall
    Open, Classified ·CP Medical Inc·Product code GAM·October 18, 2019

    Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm Manufactured by CP Medical Portland, OR USA'. Product box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm) STERILE EO Manufacturer CP Medical Portland, OR USA' . Product was distributed to single consignee, a distributor in South Africa.

    FDA Recall
    Terminated ·C P Medical·Product code GAT·April 3, 2007

    Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament Polypropylene Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm) One Dozen Sterile Manufactured by: CP Medical Portland, OR USA' . Side of box has an adhesive sticker label which includes: 'Vet Use Only'. Packet Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable Suture 18' (45 cm) STERILE EO Manufacturer: CP Medical Portland, OR USA' . Product is also distributed under two private labels, Webster Veterinary and Butler. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile 07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only Distributed by: Webster Veterinary Supply, Inc. 07-836-4643(8665P) 26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'. Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm 01-B8665P-01 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene Monofilament Synthetic Nonabsorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.

    FDA Recall
    Terminated ·C P Medical·Product code GAW·April 3, 2007

    Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.

    FDA Recall
    Open, Classified ·CP Medical Inc·Product code GAL·February 4, 2019

    Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) MONO-DOX Violet Monofilament Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2 19 mm 3/8 CUTTING Manufactured by: CP Medical Portland, OR USA 30' (75 cm) One Dozen Sterile Synthetic Absorbable Suture '. Packet Label includes: '3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm) POLYDIOXANONE Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE EO Manufacturer: CP Medical Portland, OR USA' . Product is also distributed under three private labels, Webster Veterinary, Butler, and Phoenix Pharmaceutical, Inc. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone Suture Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01 Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX Violet Monofilament Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use Only Distributed by: Webster Veterinary Supply, Inc. CUTTING NFS-2 3/8 19mm 26-SM398A-01'. Butler Box label includes: 'Butler 3/0 (2.0 metric) MONOSORB Violet Monofilament Polydioxanone Suture 029254 Vet Use Only NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 30' (75cm) 029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic Absorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'. Phoenix Pharmaceutical Box label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic Absorbable Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'. Phoenix Pharmaceutical Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile, Synthetic Absorbable Suture Veterinary Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'.

    FDA Recall
    Terminated ·C P Medical·Product code GAM·April 3, 2007

    Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR USA". Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.

    FDA Recall
    Terminated ·C P Medical·Product code NEW·September 17, 2008