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Sources: EU EUDAMED, US FDA
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The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·August 9, 2022
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
FDA Recall
Open, Classified
·Echonous Inc·Product code IYN·May 9, 2024
MAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
FDA Recall
Open, Classified
·REPLIGEN CORPORATION·December 10, 2025
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
FDA Recall
Open, Classified
·Cardinal Health·Product code FCM·November 1, 2022
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code MQK·April 1, 2022
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
FDA Recall
Open, Classified
·Centerline Biomedical Inc·Product code DQK·April 11, 2025
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
FDA Recall
Open, Classified
·Onkos Surgical, Inc.·Product code QHQ·May 20, 2025
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·March 30, 2022
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
FDA Recall
Open, Classified
·Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany·Product code HIH·June 23, 2023
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
FDA Recall
Open, Classified
·WANDERCRAFT SAS·Product code PHL·April 3, 2025
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FMF·May 23, 2025
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
FDA Recall
Open, Classified
·Cardinal Health·Product code FCM·November 1, 2022
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code FZX·November 30, 2023
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
FDA Recall
Open, Classified
·Cardinal Health·Product code FCM·November 1, 2022
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
FDA Recall
Open, Classified
·Cardinal Health·Product code FCM·November 1, 2022
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024