Class IIICompletedZ-2092-2025
STRATASYS LTD recalls TrueDent Magenta
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month.…
STRATASYS LTDJul 16, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,525–1,536 of 2,908 recalls
Class IIICompletedZ-2091-2025
STRATASYS LTD recalls TrueDent Cyan
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month.…
STRATASYS LTDJul 16, 2025
Class IIICompletedZ-2090-2025
STRATASYS LTD recalls TrueDent Clear
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month.…
STRATASYS LTDJul 16, 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