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    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 13) TLH PACK, REF DYNJ42792D; 14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L; 15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L; 16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K; 17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J; 18) DA VINCI HYSTERECTOMY, REF DYNJ44863O; 19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 20) LAP-GYN PACK, REF DYNJ44876L; 21) LAP-GYN PACK, REF DYNJ44876M; 22) ROBOT PACK, REF DYNJ45184F; 23) GYN ROBOTIC PACK, REF DYNJ47766Q; 24) ST. ANNE'S MULTI PORT PACK, REF DYNJ48638G; 25) RBTC COLON/KIDNEY PK RFID-LF, REF DYNJ52397M; 26) GYN LAP PACK, REF DYNJ52524C; 27) ROBOTIC PACK, REF DYNJ53650D; 28) LAPAROTOMY PACK, REF DYNJ59079D; 29) ROBOTIC GYN PACK, REF DYNJ62107B; 30) GYN UROL BASIC LAPAROSCOPY, REF DYNJ63326D; 31) FAIRFAX DAVINCI TRAY, REF DYNJ63606C; 32) GYN LAP PACK, REF DYNJ64234B; 33) ROBOT GYN SHARED, REF DYNJ64793A; 34) ROBOT GYN SHARED, REF DYNJ64793B; 35) ROBOT GYN SHARED, REF DYNJ64793C; 36) GYN DAVINCI PACK, REF DYNJ65373A; 37) ROBOT PACK, REF DYNJ67190C; 38) TUBAL LIGATION PACK, REF DYNJ68563A; 39) TUBAL LIGATION PACK, REF DYNJ68563B; 40) DAVINCI GYN PACK, REF DYNJ69169A; 41) GYN LAPAROSCOPY PACK, REF DYNJ69490C; 42) ROBOTIC PACK, REF DYNJ84776A; 43) ROBOTIC LAVH, REF DYNJ901281G; 44) ROBOTIC LAP CHOLE, REF DYNJ901282J; 45) GYN LAPAROTOMY, REF DYNJ902498J; 46) WMC ROBOTIC BASE-LF, REF DYNJ902583M; 47) HHI ROBOTIC CDS, REF DYNJ902953G; 48) HHI ROBOTIC CDS, REF DYNJ902953I; 49) HHI ROBOTIC CDS, REF DYNJ902953J; 50) HHI ROBOTIC CDS, REF DYNJ902953K; 51) ROBOTIC GYN & GU, REF DYNJ903459F; 52) SM DAVINCI, REF DYNJ903539G; 53) WEST GYN LAPAROSCOPY, REF DYNJ904490I; 54) ROBOTIC GYN, REF DYNJ904792C; 55) ROBOTIC GENERAL, REF DYNJ904793B; 56) ROBOT, REF DYNJ906112B; 57) ROBOTIC URO LH, REF DYNJ906445A; 58) ROBOTIC URO LH, REF DYNJ906445B; 59) ROBOTIC URO LH, REF DYNJ906445C; 60) WMC THORACIC ROBOTIC, REF DYNJ907153C; 61) DAVINCI, REF DYNJ907392A; 62) DAVINCI, REF DYNJ907392B; 63) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396B; 64) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396C; 65) GYN LAPAROSCOPY - NTSC, REF DYNJ907407A; 66) GYN LAPAROSCOPY - NTSC, REF DYNJ907407B; 67) ROBOTIC-LF, REF DYNJ907910; 68) ROBOTIC-LF, REF DYNJ907910A; 69) GU DAVINCI KIT, REF DYNJ908783; 70) GU DAVINCI KIT, REF DYNJ908783A; 71) GU DAVINCI PACK - LF, REF DYNJ909398A; 72) GYN LAPAROSCOPY, REF DYNJ910084; 73) MHPB GYN ROBOTIC PACK, REF DYNJ910125;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OHD·October 9, 2024

    Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HHI·September 12, 2019

    Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.

    FDA Recall
    Terminated ·Richard Wolf Medical Instruments Corp.·Product code HHI·May 19, 2016

    Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MLT·April 8, 2024

    HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJX·April 24, 2025

    "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***" The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code MBI·January 26, 2011

    Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM)Injection Sites and Rotating Male Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc; with 2""Hi-Flo" Stopcocks, Twin Y Injection Sites and Detachable 8" Extension with Retractable Luer-Lock; with Two SmartSite(TM) Y-injection Sites. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with Ball Pump 4-Way 3-Gang Stopcock Manifold and 4 SmartSite(TM) Y-Injection Sites SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with 2 "Hi-Flo" Stopcocks, Two Y Injection Sites and Detachable 8" Extension with Option Lock; with 2 Vented Spikes and Double "Hi-Flo" Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.

    FDA Recall
    Terminated ·Sunrise Medical HHG Inc. dba DeVilbiss Healthcare·Product code BZD·March 11, 2011

    Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such.

    FDA Recall
    Terminated ·Rite-Dent Manufacturing Corp.·Product code EHY·September 21, 2005

    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CHI·June 26, 2020

    Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944

    FDA Recall
    Terminated ·Horiba Instruments Incorporated·Product code CHI·October 30, 2018

    Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.

    FDA Recall
    Terminated ·Genzyme Corporation·Product code CHI·April 14, 2008

    Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .

    FDA Recall
    Terminated ·Genzyme Corporation·Product code CHI·April 14, 2008

    Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CHI·June 26, 2020

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006

    SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code CHI·October 25, 2004

    Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CHI·June 1, 2007

    Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHI·September 7, 2018

    VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code CHI·September 12, 2023