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    FUJINON COLONOSCOPES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Plum A+ v.11.X, list #s 12391-04-01, 12391-04-03, 12391-04-05, 12391-04-11, 12391-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code FRN·August 11, 2009

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 18, 2022

    BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MAC-LINE CO2 NASAL CANNULA SAMPLE LINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOWRIST FENESTRATED BIPOLAR FORCEPS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·March 5, 2024

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

    FLOOR MOUNT FASTENER SNGL PLT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 14, 2013

    ADAPTER SLEEVES 12/14 +8

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·September 23, 2014

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·May 27, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 19, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 19, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 13, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 29, 2022

    The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming feature.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·June 15, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025