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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 3521–3540 of 39,430 recalls

Class IIOngoing

Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

Tornier S.A.S.

A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

April 10, 2025 · DeviceView details →

Class IIOngoing

CMS8000 Patient Monitor

Contec Medical Systems Co., Ltd.

Patient monitor has nine identified cybersecurity vulnerabilities.

April 10, 2025 · DeviceView details →

Class I

Ongoing

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.

Vyaire Medical

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

April 10, 2025 · DeviceView details →

Class IIOngoing

Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395

MEDLINE INDUSTRIES, LP - Northfield

Three is the potential for the retractors to puncture through the sterile packaging.

April 9, 2025 · DeviceView details →

Class IIOngoing

FoundationOne Companion Diagnostic (F1CDx)

Foundation Medicine, Inc.

Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.

April 9, 2025 · DeviceView details →

Class IIOngoing

PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).

Richard Wolf GmbH

The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

April 9, 2025 · DeviceView details →

Class IIOngoing

Centurion Sterile Weitlaner Retractor, Reorder: 67315

MEDLINE INDUSTRIES, LP - Northfield

Three is the potential for the retractors to puncture through the sterile packaging.

April 9, 2025 · DeviceView details →

Class IIOngoing

Artix MT Thrombectomy Device, REF: 32-102

Inari Medical - Oak Canyon

Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.

April 8, 2025 · DeviceView details →

Class IIOngoing

REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing, archiving and restoration of patient results.

Beckman Coulter Inc.

Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.

April 8, 2025 · DeviceView details →

Class IIOngoing

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.

Philips North America Llc

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

April 7, 2025 · DeviceView details →

Class IIOngoing

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Philips Medical Systems Nederland B.V.

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

April 7, 2025 · DeviceView details →

Class IIOngoing

Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

SCIENCE & BIO MATERIALS

Vials of implant bone granules may contain less product then specified on labeling.

April 7, 2025 · DeviceView details →

Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.

Baxter Healthcare Corporation

A cybersecurity vulnerability was discovered through internal testing.

April 7, 2025 · DeviceView details →

Class IIOngoing

Molding Equipment. WCM series. Model WCM-330GL-i

Apic Yamada America

Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.

April 7, 2025 · DeviceView details →

Class IIOngoing

Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

Ambu Inc.

Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.

April 7, 2025 · DeviceView details →

Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.

Baxter Healthcare Corporation

A cybersecurity vulnerability was discovered through internal testing.

April 7, 2025 · DeviceView details →

Class IIOngoing

INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.

Integra LifeSciences Corp. (NeuroSciences)

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

April 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No

Olympus Corporation of the Americas

Preset treatment parameters are not consistently being used in accordance with the IFU.

April 4, 2025 · DeviceView details →

Class IIOngoing

KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

Klinika Mdical Gmb

Potential for microbial contamination.

April 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Micro-X Ltd.

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

April 4, 2025 · DeviceView details →

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