Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation,…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood…
Class IFDA: OngoingMedical Action Industries, Inc. 306
This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may…
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the…
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the…
This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall…
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation,…
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation,…
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or…
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation,…
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to…
Class IIFDA: OngoingWindstone Medical Packaging, Inc.
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation,…
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the…
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device.…
Class IIFDA: OngoingTerex Utilities
About the 2026 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.