BEUDAMED
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    Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision 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

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

    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FWZ·February 14, 2024

    Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBB·November 30, 2009

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017

    1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).

    FDA Recall
    Open, Classified ·Westmed, Inc.·Product code BZA·September 27, 2024

    Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.

    FDA Recall
    Terminated ·Musculoskeletal Transplant Foundation, Inc.·Product code HXY·May 27, 2015

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    FDA Recall
    Terminated ·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016

    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

    FDA Recall
    Terminated ·Allen Medical Systems·Product code JEB·October 6, 2017

    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

    FDA Recall
    Terminated ·SunMed Holdings, LLC·Product code CBT·September 8, 2022

    Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

    FDA Recall
    Terminated ·Allen Medical Systems·Product code JEB·October 6, 2017

    Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code BTM·May 1, 2025

    Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.

    FDA Recall
    Terminated ·Musculoskeletal Transplant Foundation, Inc.·Product code MBP·April 21, 2016

    DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100

    FDA Recall
    Open, Classified ·Musculoskeletal Transplant Foundation, Inc.·Product code MQV·September 22, 2023

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013

    AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code CAE·December 22, 2022

    Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

    FDA Recall
    Terminated ·Allergan Inc·Product code LCJ·June 18, 2015

    F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

    FDA Recall
    Terminated ·Allen Medical Systems·Product code N/A·February 21, 2018

    Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

    FDA Recall
    Terminated ·Allergan Inc·Product code MRD·June 8, 2015

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No

    FDA Recall
    Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A

    FDA Recall
    Open, Classified ·Avanos Medical, Inc.·Product code BSY·March 19, 2025