Class IOngoingZ-2102-2025
Intersurgical Inc recalls i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is…
Potential for faulty devices as a result of depleted batteries.
Intersurgical IncNYJul 23, 2025
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 409–420 of 595 recalls
Class IOngoingZ-2096-2025
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump V8
Certain Spectrum infusion pumps may have an incorrect version of software.
Baxter Healthcare Corp…ILJul 23, 2025
Class IOngoingZ-2095-2025
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump V6
Certain Spectrum infusion pumps may have an incorrect version of software.
Baxter Healthcare Corp…ILJul 23, 2025
Class IOngoingZ-2085-2025
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: F…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Edwards Lifesciences,…CAJul 16, 2025
Class IOngoingZ-2084-2025
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Edwards Lifesciences,…CAJul 16, 2025
Class IOngoingZ-2083-2025
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Edwards Lifesciences,…CAJul 16, 2025
Class IOngoingZ-2082-2025
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Edwards Lifesciences,…CAJul 16, 2025
Class IOngoingZ-2081-2025
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/C…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Edwards Lifesciences,…CAJul 16, 2025
Class IOngoingZ-2080-2025
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/C…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Edwards Lifesciences,…CAJul 16, 2025
Class IOngoingZ-2047-2025
Given Imaging Ltd. recalls Bravo CF capsule delivery device
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus…
Given Imaging Ltd.Jul 16, 2025
Class IOngoingZ-2032-2025
Baxter Healthcare Corporation recalls Hillrom LikoScale component
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories.…
Baxter Healthcare Corp…ILJul 16, 2025
Class IOngoingZ-2031-2025
Baxter Healthcare Corporation recalls Hillrom Q-Link 13 component
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories.…
Baxter Healthcare Corp…ILJul 16, 2025