BEUDAMED
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    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303

    FDA Recall
    Terminated ·Tytek Medical Inc·Product code GAA·October 5, 2020

    TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317

    FDA Recall
    Terminated ·Tytek Medical Inc·Product code GAA·October 5, 2020

    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

    FDA Recall
    Terminated ·Tytek Medical Inc·Product code BWC·November 15, 2019

    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310

    FDA Recall
    Terminated ·Tytek Medical Inc·Product code GAA·October 5, 2020

    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

    FDA Recall
    Terminated ·Smiths Medical Asd Inc·Product code FPA·May 4, 2015

    Vortex Surgical I2 Injection Kit, VS0500

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code KDD·December 16, 2025

    Tecfen Retractable Membrane Polisher, QTPR1267-23

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HNQ·December 16, 2025

    25GA Subretinal Injection Cannula VS0220.25

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code MXY·December 16, 2025

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code KDD·December 16, 2025

    Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code MXY·December 16, 2025

    Rumex Disposable Diamond Dusted ILM Elevator, 12-7523

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HNQ·December 16, 2025

    Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code MXY·December 16, 2025

    Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HMQ·December 16, 2025

    Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HJK·December 16, 2025

    Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HQB·December 16, 2025

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Recall
    Terminated ·Ecolab Inc·Product code LHC·August 18, 2015

    Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HQB·December 16, 2025

    LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray is then sterilized. The primary sterile barrier is the inner sealed tray.

    FDA Recall
    Terminated ·Horizon Medical Products Inc·Product code LJT·September 20, 2004

    MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case; Manufactured by Medisav Services Inc. (MSI), 56 Elson Street, Markham, Ontario L3S 1Y7 Canada

    FDA Recall
    Terminated ·Elite Medical Group·Product code MPN--·July 3, 2003

    Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HNR·December 16, 2025