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    Filters FDA Recall × Status: Terminated × Clear all

    LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IDZ·April 4, 2013

    Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010

    VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components: Elution Buffer A, 2 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; CD-ROM - Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water Whole Blood Primer, 6 x 1 mL Sample Vials, 2 x 100 Instruction Manual. Bio-Rad Laboratories Inc. Hercules, CA 94547 Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·July 28, 2011

    12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.

    FDA Recall
    Terminated ·Spectranetics Corp.·Product code LPC·March 13, 2012

    ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

    FDA Recall
    Terminated ·Spectranetics Corporation·Product code LPC·October 31, 2016

    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·July 10, 2017

    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA; 7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED 1/EA; 8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED 1/EA; 9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU 1/EA; 13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU 1/EA; 14. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU 1/EA; 15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU 1/EA; 16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL 1/EA; 17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO 1/EA; 18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO 1/EA; 30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO 1/EA; 32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO 1/EA; 33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO 1/EA; 34. TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED 1/EA;

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·July 8, 2019

    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan·Product code NGY·February 20, 2023

    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.

    FDA Recall
    Terminated ·Progressive Medical Inc·Product code GDI·October 28, 2011

    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DYB·November 23, 2015

    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.

    FDA Recall
    Terminated ·Progressive Medical Inc·Product code GDI·December 9, 2011

    1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019

    2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019