Class IIOngoingZ-2219-2026
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 385–396 of 3,866 recalls
Class IIOngoingZ-2218-2026
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2217-2026
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2216-2026
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2215-2026
Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2214-2026
Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2213-2026
Novapproach Spine, LLC recalls OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and…
Novapproach Spine, LLCFLMay 27, 2026
Class IIOngoingZ-2210-2026
ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption…
ICU Medical, Inc.CAMay 27, 2026
Class IIOngoingZ-2209-2026
TANGENT ENDOSCOPY, LLC recalls Tangent Endoscopy
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
TANGENT ENDOSCOPY, LLCDEMay 27, 2026
Class IIOngoingZ-2204-2026
Becton, Dickinson And Company recalls Swan-Ganz Pacing Catheter
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Becton, Dickinson and…CAMay 27, 2026
Class IIOngoingZ-2203-2026
Becton, Dickinson And Company recalls Swan-Ganz Jr Catheter
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Becton, Dickinson and…CAMay 27, 2026
Class IIOngoingZ-2202-2026
Becton, Dickinson And Company recalls Swan-Ganz Catheter
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Becton, Dickinson and…CAMay 27, 2026