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Showing 6641–6660 of 11714 results

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Presource PBDS Kit (Cardinal Health) – Component Issue (2023)

XXX

Low

FDAAug 16, 2023Nationwide• Cardinal Health 200, LLC

Presource PBDS Kit (Cardinal Health) – Recalled Components (2023)

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Low

FDAAug 16, 2023Nationwide• Cardinal Health 200, LLC

Gallant HF Defibrillator (Abbott) – Bluetooth Malfunction (2023)

Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.

High

FDAAug 16, 2023Nationwide• Abbott Medical

Philips Allura Xper (Philips) – Foot Switch Damage (2023)

A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

Moderate

FDAAug 15, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Remel Todd Hewitt Broth (Remel) – Organism Recovery Issue (2023)

On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

Moderate

FDAAug 14, 2023Nationwide• Remel, Inc

KWIK-STIK QC Set (Microbiologics) – Missing Strain (2023)

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

Low

FDAAug 14, 2023Nationwide• Microbiologics Inc

OTC Drug Products (Inmar) – potential rodent exposure (2023)

CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.

Class IIModerate

FDAAug 14, 2023Nationwide• Inmar Supply Chain Solutions, LLC

Trandolapril/Verapamil Tablets (Glenmark) – subpotent medication (2023)

Subpotent: Out of Specification for Assay Test at the 3-month time point.

Class IIILow

FDAAug 14, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Epiphany Cardio Server (Baxter) – Software Correction (2023)

Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.

Moderate

FDAAug 10, 2023Nationwide• Baxter Healthcare Corporation

Functional MR Software (Olea Medical) – Export Error (2023)

When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.

Moderate

FDAAug 10, 2023MA, MI• OLEA MEDICAL 93 AVANUE DU SORBIER, ZONE ATHELIA IV LA CIOTAT France

Guardian 2 System (Turncare) – Battery Alert Software (2023)

A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

Moderate

FDAAug 10, 2023Nationwide• Turncare, Inc

Veran Endobronchial Access Catheter (Olympus) – Navigation System Problem (2023)

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

Moderate

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Veran Percutaneous Biopsy Kit (Olympus) – Navigation System Issue (2023)

Moderate

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

PDS Plus Antibacterial Suture (Ethicon) – Tensile Strength Failure (2023)

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

Moderate

FDAAug 10, 2023Nationwide• ETHICON, LLC

Veran Endobronchial Needle (Olympus) – Navigation System Problem (2023)

Moderate

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Arrow Pressure Injectable CVC (Arrow) – Product Label Mismatch (2023)

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Moderate

FDAAug 10, 2023Nationwide• ARROW INTERNATIONAL Inc.

PDS II Suture (Ethicon) – Tensile Strength Failure (2023)

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

Moderate

FDAAug 10, 2023Nationwide• ETHICON, LLC

Veran Thoracic Navigation System (Olympus) – Device Nonconformance (2023)

Moderate

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Veran Percutaneous Track Device (Olympus) – Navigation System Nonconformance (2023)

Moderate

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Arrow ErgoPack (Arrow) – Product Label Mismatch (2023)

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Moderate

FDAAug 10, 2023Nationwide• ARROW INTERNATIONAL Inc.

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