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Showing 1301–1320 of 8389 results

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CADD-Solis Infusion Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CMS8000 Patient Monitor (Contec) – Cybersecurity Risk (2025)

Patient monitor has nine identified cybersecurity vulnerabilities.

FDAApr 10, 2025Nationwide• Contec Medical Systems Co., Ltd. Economic And No.

CADD Solis Pump (Smiths Medical) – Wireless Connection (2025)

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Very High

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis HPCA Pump (Smiths Medical) – Occlusion Alarm (2025)

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

PiezoWave 2 Control Unit (Richard Wolf) – Capacitor Failure (2025)

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.

FDAApr 9, 2025GA• Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany

FoundationOne Diagnostic (Foundation Medicine) – Variant Reporting (2025)

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.

FDAApr 9, 2025Nationwide• Foundation Medicine, Inc.

Centurion Weitlaner Retractor (Medline) – Packaging Integrity (2025)

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

FDAApr 9, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Artix MT Thrombectomy Device (Inari) – Vessel Range (2025)

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.

FDAApr 8, 2025Nationwide• Inari Medical Oak Canyon

REMISOL Advance Software (Beckman Coulter) – Date Processing (2025)

Laceration Risk

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.

FDAApr 8, 2025Nationwide• Beckman Coulter Inc.

WCM Series Molding Equipment (Apic Yamada) – FDA Compliance Issue (2025)

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.

FDAApr 7, 2025Nationwide• Apic Yamada America

Welch Allyn Life2000 Compressor (Baxter Healthcare) – Cybersecurity Vulnerability (2025)

A cybersecurity vulnerability was discovered through internal testing.

FDAApr 7, 2025Nationwide• Baxter Healthcare Corporation

Ambu aScope 5 Broncho (Ambu) – Incorrect Labeling (2025)

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.

FDAApr 7, 2025Nationwide• Ambu Inc.

Welch Allyn Life2000 Ventilation System (Baxter Healthcare) – Cybersecurity Vulnerability (2025)

A cybersecurity vulnerability was discovered through internal testing.

FDAApr 7, 2025Nationwide• Baxter Healthcare Corporation

Bio 1 Granules (Science & Bio Materials) – Insufficient Product Volume (2025)

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

FDAApr 7, 2025Nationwide• SCIENCE & BIO MATERIALS Zi Du Monge Lourdes France

Microstream Advance CO2 Filter (Philips) – Adapter Disconnection Risk (2025)

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

FDAApr 7, 2025Nationwide• Philips North America Llc

INSPIRA AIR Balloon Dilation System (Integra LifeSciences) – Incorrect Product Packaging (2025)

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

FDAApr 4, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

KliniTray Tissue Margin Board (Klinika Medical) – Microbial Contamination (2025)

Potential for microbial contamination.

FDAApr 4, 2025Nationwide• Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany

KliniTray Faxitron Plate (Klinika Medical) – Microbial Contamination (2025)

Potential for microbial contamination.

FDAApr 4, 2025Nationwide• Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany

SOLTIVE Pro SuperPul Laser Instrument (Olympus) – Treatment Parameter Deviation (2025)

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

FDAApr 4, 2025Nationwide• Olympus Corporation of the Americas

Rover Mobile X-Ray System (Micro-X) – Generator Mechanism Failure (2025)

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

FDAApr 4, 2025NJ, WA, PR• Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia

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