PQI - BEUDAMED

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

FDA Recall

Terminated ·Clinical Innovations, LLC·Product code OQY·January 5, 2015

Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.

FDA Recall

Terminated ·Butterfly Network, Inc.·Product code IYN·February 24, 2020

Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit

FDA Recall

Terminated ·Taut, Inc.·Product code GBW·January 19, 2007

Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).

FDA Recall

Terminated ·Psi Health Solutions·Product code MVV·April 26, 2007

Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

FDA Recall

Terminated ·Signature Orthopedics Pty Limited·Product code MEH·February 2, 2018

Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

FDA Recall

Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.

FDA Recall

Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

FDA Recall

Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

Ellex Super Q LQP3106 ophthalmic laser

FDA Recall

Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

Cocoon Convective Warming System, Product Code: CWS5000 (110V).

FDA Recall

Terminated ·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

FDA Recall

Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025

Alcon 3000LE ophthalmic laser

FDA Recall

Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Recall

Terminated ·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

FDA Recall

Open, Classified ·Ellex Medical Pty Ltd.·Product code HQF·March 16, 2023

Ellex Tango LT5106-T ophthalmic laser (not sold in USA)

FDA Recall

Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

Ellex Ultra Q LQP3106-U ophthalmic laser

FDA Recall

Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

FDA Recall

Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

FDA Recall

Open, Classified ·Leica Biosystems Melbourne Pty Ltd·Product code IEO·April 2, 2025

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

FDA Recall

Open, Classified ·Oxoid Australia Pty Limited 20 Dlgleish St South Australia Australia·Product code LQL·March 3, 2026

Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).

FDA Recall

Open, Classified ·SEER MEDICAL PTY LTD 278-284 Queensberry St Melbourne Australia·Product code GWQ·August 12, 2024