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Showing 1501–1520 of 8389 results

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TruSystem 7500 Mobile Column (Baxter) – Software Control Fault (2025)

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

Progressa Bed Surfaces (Baxter) – Air Bladder Movement (2025)

The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

COR Disposable Kit (DePuy Mitek) – Missing Graft Loader Pin (2025)

Device is missing the pin in the graft loader component.

Moderate

FDAFeb 24, 2025Nationwide• DePuy Mitek, Inc., a Johnson & Johnson Co.

Medline Convenience Kits (Medline) – Tube Recall Issue (2025)

Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

FDAFeb 24, 2025CA• MEDLINE INDUSTRIES, LP Northfield

Checkpoint Guardian Lead (Checkpoint Surgical) – Adhesive Encapsulation Fault (2025)

Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

FDAFeb 24, 2025Nationwide• Checkpoint Surgical Inc

COR Disposable Kit (DePuy Mitek) – Missing Pin (2025)

Device is missing the pin in the graft loader component.

FDAFeb 24, 2025Nationwide• DePuy Mitek, Inc., a Johnson & Johnson Co.

Boppli Bedside Device Kit (PYRAMES) – Noise Detection Issue (2025)

Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.

FDAFeb 24, 2025CA, MA• PYRAMES INC

Medline Procedure Kits (Medline) – Cannula Concern (2025)

Medline medical procedure kits, containing Medtronic Aortic Root Cannula

FDAFeb 21, 2025CA, FL, MN +6 more• MEDLINE INDUSTRIES, LP Northfield

Medline Procedure Kits (Medline) – Male Luer Material Issue (2025)

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

FDAFeb 21, 2025CA, FL, MN +6 more• MEDLINE INDUSTRIES, LP Northfield

BD Connecta Luer-Lok (Unknown) – Instruction Mismatch (2025)

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

FDAFeb 20, 2025AL, AK, AZ +32 more

IVX Station Transfer Set (Omnicell) – Premature Deployment (2025)

IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.

FDAFeb 20, 2025AL, IN• Omnicell, Inc.

Helix Elite SARS-CoV-2 Standard (Microbiologics) – Cell Target Delay (2025)

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

FDAFeb 20, 2025Nationwide• Microbiologics Inc

Helix Elite Influenza Standard (Microbiologics) – RSV Target Issue (2025)

The RSV target may give a late Ct value and could potentially not pass QC.

FDAFeb 20, 2025Nationwide• Microbiologics Inc

Orthofix Pillar SA Spacer (Orthofix) – Mislabeled Height (2025)

The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

FDAFeb 20, 2025Nationwide• Orthofix U.S. LLC

Centricity Radiology RA600 (GE Healthcare) – Security Vulnerability (2025)

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

FDAFeb 19, 2025Nationwide• GE Healthcare

Centricity Universal Viewer (GE Healthcare) – Security Vulnerability (2025)

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

FDAFeb 19, 2025Nationwide• GE Healthcare

MIM Radiological Software (MIM Software) – Image Fusion Error (2025)

In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.

FDAFeb 19, 2025Nationwide• MIM Software Inc

Lazervida Laser Engraver (Flux Technology) – Performance Standards (2025)

Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.

FDAFeb 19, 2025Nationwide• Flux Technology Inc.

Wayson Hydrocolloid (Medline) – Sterility Compromise (2025)

There is a potential for the sterility of the device to be compromised.

FDAFeb 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Merge Cardio (Merge Healthcare) – Measurement Workflow Issue (2025)

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

FDAFeb 19, 2025Nationwide• Merge Healthcare, Inc.

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