BEUDAMED
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    LightPod ERA lasers

    FDA Recall
    Terminated ·Aerolase Corporation·Product code GEX·August 1, 2019

    Class IV New Era medical laser device

    FDA Recall
    Open, Classified ·Inova Lasers LLC·Product code GEX·January 29, 2020

    Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under names including FriendlyLight Er:YAG, LightPod Era, FriendlyLight Nd:YAG, LightPod Neo, LightPod Neo XL, LightPod Neo XT, LightPod Forte, LightPod Allure, and LightPod Nova.

    FDA Recall
    Terminated ·Aerolase·Product code GEX·June 7, 2011

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    FDA Recall
    Terminated ·New Era Orthopaedics, LLc·Product code MNI·February 13, 2017

    2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code ERA·May 9, 2025

    MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·April 24, 2014

    MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·July 9, 2019

    MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·June 20, 2011

    Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·January 26, 2012

    Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·October 17, 2016

    MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·April 13, 2016

    All Med Medical 20ga x 1" RA Hub Needle Model #M201H Reorder #55-2030 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    All Med Medical 22ga x 1" RA Hub Needle Model #M221H Reorder #55-2230 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    All Med Medical 19ga x 1" RA Hub Needle Model #M191H Reorder #55-1930 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNH·March 9, 2015

    Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy

    FDA Recall
    Terminated ·ela Medical Llc·Product code NIK·June 7, 2010

    ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

    FDA Recall
    Open, Classified ·Erbe Medical, LLC·Product code OCX·March 31, 2026

    Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.

    FDA Recall
    Terminated ·ela Medical Llc·Product code MRM·July 19, 2005