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Displaying 1 - 15 of 424 items.
Cardinal Health Cardiovascular, Bypass and Hepatobiliary Packs
The recent expansion to medical device recall from Medtronic/Covidien concerning various sutures found in some Cardinal Health Presource® kits. Specific lots of these sutures were sterilized with gamma doses that exceed the range approved or were exposed…
RecallHealth product recall | 2024-03-12
Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems
Abbott is notifying customers of a planned update to instructions for use associated with observed outflow graft deformation known as "extrinsic outflow graft obstruction" (EOGO) associated with the Heartmate 3™ left ventricular assist system (LVAS) and…
RecallHealth product recall | 2024-03-06
BD Bodyguard Microset
BD received customers complaints, that the new clamp on the y-port of the BD Bodyguard™ Microset (clamp supplied since 2021) can be opened more easily compared to the clamp which was used before 2021. Patients may accidentally lay on the infusion set and…
RecallHealth product recall | 2024-03-06
Impella Systems
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Recall start date: February 26, 2024
RecallHealth product recall | 2024-03-06
Medline Packs with Sofsilk™ Braided Silk Sutures and Ti-Cron™ Coated Braided Polyester Suture
Specific lots of the Sofsilk™ Braided Silk Sutures and Ti-Cron™ Coated Braided Polyester Sutures were sterilized with gamma doses that exceeded the range approved or were exposed to more than the approved number of ethylene oxide (EO) sterilization…
RecallHealth product recall | 2024-02-07
Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures
Specific lots of the Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures were sterilized with gamma doses that exceeded the range approved or were exposed to more than the approved number of Ethylene Oxide (EO) sterilization…
RecallHealth product recall | 2024-01-31
Philips Allura XPER, Allura Centron and Azurion Systems
Philips has become aware of issues with three (3) components in certain PCs used with the Philips Allura XPER, Allura Centron and/or Azurion systems that may result in a loss of system functionality. Three (3) components of the PCs may not perform as…
RecallHealth product recall | 2024-01-19
Philips Achieva, Intera and Ingenia Systems
The quadrature body coil (QBC) seal adhesive may fail creating sharp edges that may come in contact with patients. The QBC seal may become loose as the patient table travels in a horizontal motion in and out of the system bore. The QBC seal (figure 1) is…
RecallHealth product recall | 2024-01-17
Sofsilk™ Braided Silk Sutures
Cardinal Health was recently informed of a medical device recall from Medtronic concerning the Sofsilk™ Braided Silk Sutures referenced above. The recall is being issued due to specific lots of Sofsilk™ Braided Silk Sutures being sterilized with gamma…
RecallHealth product recall | 2024-01-17
Disposable Hasson Trocar 12/110mm
It was determined that there was a potential for the sterile packaging barrier to have been damaged and compromised during manufacturing.
Recall start date: January 2, 2024
RecallHealth product recall | 2024-01-17
BrightView XCT Imaging System and Gamma Camera System
Philips has become aware of a potential safety issue affecting BrightView systems where the detector may unexpectedly fall due to a component failure.
A detector support component may fail due to unexpected wear:
Scenario 1: If the detector is…
RecallHealth product recall | 2024-01-05
0.9% SODIUM CHLORIDE INJECTION, USP: Solution bags may be leaking in affected lots. (Updated with new lot numbers)
Solution bags may be leaking in affected lots.
RecallHealth product recall | 2023-12-24
Bleomycin for Injection USP: Glass Particulate
Affected lot may contain glass particulate.
RecallHealth product recall | 2023-12-21
INGENIO, INLIVEN, INVIVE and VITALIO Pacemakers
Field Safety Notice was initiated due to the potential for the INGENIO family to exhibit a high battery impedance later in device life and initiate safety mode. Most safety mode reports continue to be associated with telemetry operations with a small…
RecallHealth product recall | 2023-12-20
Alaris™ GH Plus Guardrails™ Syringe Pump
BD is issuing a notification to inform customers that Cardinal Health branded Monoject™ syringes have not been validated for use with the BD Alaris™ infusion devices. BD has validated Covidien branded Monoject™ syringes for use with the BD Alaris™…
RecallHealth product recall | 2023-12-20