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Showing 1341–1360 of 8393 results

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Triton Ultrasonic Cleaning Systems (Ultra Clean) – Sensor Degradation (2025)

During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.

FDAMar 31, 2025Nationwide• Ultra Clean Systems, Inc.

Guide Wire with Ruler Tube (Stryker) – Metal Ring Detachment Risk (2025)

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

FDAMar 28, 2025Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Guide Wire with Ruler Tube (Stryker) – Metal Ring Detachment Risk (2025)

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

Moderate

FDAMar 28, 2025Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

B Braun Elite HV Hemostasis Valve (Galt Medical) – Sterile Packaging Seal (2025)

Due to a potential open seal in the sterile barrier packaging .

FDAMar 27, 2025Nationwide• Galt Medical Corporation

B Braun Coaxial Dilator (Galt Medical) – Sterile Packaging Seal (2025)

Due to a potential open seal in the sterile barrier packaging .

FDAMar 27, 2025Nationwide• Galt Medical Corporation

enVista Monofocal IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

FDAMar 27, 2025Nationwide• Bausch & Lomb Surgical, Inc.

enVista Envy IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

FDAMar 27, 2025Nationwide• Bausch & Lomb Surgical, Inc.

Galt Centeze Catheter (Galt Medical) – Sterile Packaging Seal (2025)

Due to a potential open seal in the sterile barrier packaging .

FDAMar 27, 2025Nationwide• Galt Medical Corporation

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Host System Connectivity (2025)

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

FDAMar 27, 2025Nationwide• Beckman Coulter, Inc.

Skytron Freedom Monitor Mount (IHB Operations) – Mounting Hardware Risk (2025)

The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.

FDAMar 27, 2025Nationwide• IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands

Galt Guidewire (Galt Medical) – Sterile Packaging Seal (2025)

Due to a potential open seal in the sterile barrier packaging.

FDAMar 27, 2025Nationwide• Galt Medical Corporation

Introducer Kit Coaxial Dilator (Galt Medical) – Sterile Packaging Seal (2025)

Due to a potential open seal in the sterile barrier packaging.

FDAMar 27, 2025Nationwide• Galt Medical Corporation

Introducer Tearaway MicroSlide (Galt Medical) – Sterile Packaging Seal (2025)

Due to a potential open seal in the sterile barrier packaging.

FDAMar 27, 2025Nationwide• Galt Medical Corporation

Introducer Needle (Galt Medical) – Sterile Packaging Seal (2025)

Due to a potential open seal in the sterile barrier packaging.

FDAMar 27, 2025Nationwide• Galt Medical Corporation

Trimble RTS873 Robotic Station (Trimble) – Laser Output Power (2025)

An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser safety Class 2 classification.

FDAMar 26, 2025Nationwide• Trimble Ab Rinkebyvagen 17 Danderyd Sweden

Restor3d Cordera Hip System (Conformis) – Incorrect Liner Labeling (2025)

The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.

FDAMar 25, 2025Nationwide• Conformis Inc.

IceSeed 1.5 CX S Needle OUS (Boston Scientific) – Demo Settings Issue (2025)

Laceration Risk

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

FDAMar 24, 2025Nationwide• Boston Scientific Corporation

Intera 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 1.5T Omni/Stellar (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 3.0T Quasar Dual (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

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