BEUDAMED
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    Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi International, Inc.' 670 Almanor Ave. Sunnyvale, CA 94085.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·October 11, 2011

    Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium complex 4.5 ng/mL; Rx only Product Usage: Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHP·March 7, 2016

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Recall
    Terminated ·SA3, LLC·Product code OLR·February 21, 2022

    a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FRO·May 25, 2022

    CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

    FDA Recall
    Terminated ·LMS Medical Systems Ltd·Product code HGM·January 11, 2005

    Philips Avalon Fetal Monitor FM30; Model Number: M2703A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

    Philips Avalon Fetal Monitor FM20; Model Number: M2702A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

    Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code HGM·October 24, 2025

    GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical data management system.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008

    HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems.

    FDA Recall
    Terminated ·EUROTROL INC·Product code GGM·October 18, 2018

    Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code HGM·May 26, 2026

    Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code HGM·May 26, 2026

    GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is

    FDA Recall
    Terminated ·GE Medical Systems Information Technologies·Product code HGM·May 21, 2003

    Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code HGM·October 24, 2025

    Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.

    FDA Recall
    Terminated ·GE Healthcare It·Product code HGM·March 11, 2013

    Bravo pH Monitoring System Receiver

    FDA Recall
    Terminated ·Medtronic Gastroenterology Urology·Product code FGM·February 6, 2004