BEUDAMED
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    C315-HIS Delivery Catheter

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code DQY·September 9, 2021

    The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code DQY·April 20, 2022

    Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.

    FDA Recall
    Open, Classified ·Altasource LLC dba Meta Labs LLC·Product code NA·February 3, 2014

    LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code HIS·June 23, 2022

    Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .

    FDA Recall
    Open, Classified ·GOLD STAR DISTRIBUTION INC·Product code HIS·December 26, 2025

    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

    FDA Recall
    Open, Classified ·Brainlab AG Olof-Palme-Str. 9 Munich Germany·Product code LLZ·February 10, 2025

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code LWS·December 2, 2020

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code LWS·December 2, 2020

    Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

    FDA Recall
    Open, Classified ·LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany·Product code IDW·May 10, 2024

    Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·March 22, 2021

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023

    Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·March 22, 2021

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023

    Philips Spectral CT on Rails. Model Number: 728334.

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS·Product code JAK·March 7, 2026

    AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

    FDA Recall
    Open, Classified ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code OUG·March 8, 2023

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code OLO·August 7, 2024

    32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LPH·December 21, 2021

    Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code KTT·December 21, 2021

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024