BEUDAMED
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    Filters FDA Recall × Status: Open, Classified × Clear all

    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

    FDA Recall
    Open, Classified ·Product code OEZ·May 4, 2026

    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

    FDA Recall
    Open, Classified ·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025

    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    FDA Recall
    Open, Classified ·Product code JIN·October 2, 2023

    NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456

    FDA Recall
    Open, Classified ·NxStage Medical Inc·Product code KPO·May 14, 2024

    React Health PHOENIX 5L Oxygen Concentrator

    FDA Recall
    Open, Classified ·3B Medical, Inc. 5475 Rings Rd Ste 550 Dublin OH 43017-7537·Product code CAW·February 4, 2026

    TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LPH·February 27, 2024

    TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LPH·February 27, 2024

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LPH·July 14, 2023

    TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LPH·February 27, 2024

    EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.

    FDA Recall
    Open, Classified ·Product code LPH·September 9, 2020

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55

    FDA Recall
    Open, Classified ·BioPro, Inc.·Product code LPH·September 9, 2025

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LPH·February 27, 2024

    TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LPH·February 27, 2024

    G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

    FDA Recall
    Open, Classified ·Biomet, Inc.·Product code LPH·February 6, 2023

    EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C

    FDA Recall
    Open, Classified ·Product code LPH·January 5, 2026