FDA (Devices) recall action 94274
The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.
Potential for unsealed sterile packing.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic recalled 250 units of DLP Coronary Ostial Cannulae (Model 30050) due to potential unsealed sterile packing. Lot 2023070529 was distributed worldwide.
Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.
Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing. No illnesses or injuries have been reported.
Medtronic is recalling 500 units of Clearview Blower/Mister Model 22120 due to potential for unsealed sterile packing that could compromise device sterility.
Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.
Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.
Medtronic is recalling 5,719 vessel cannulae units due to potential for unsealed sterile packing, affecting worldwide distribution.
Medtronic Intracoronary Shunts may have compromised sterile packaging, potentially allowing contamination. The FDA Class II recall affects 1,410 units distributed worldwide.
Medtronic recalls over 13,000 Left Heart Vent Catheter units due to potential for unsealed sterile packing. Affected devices distributed worldwide.
Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.
Medtronic is recalling multiple models of suction tubes due to potential for unsealed sterile packing, which could compromise device sterility. Affected customers should refer to the official FDA recall notice for lot details.
Medtronic is recalling 7,935 units of I.M.A. Arteriotomy Cannula Model 31001 worldwide due to potential for unsealed sterile packing. Affected healthcare providers should verify lot numbers against inventory.
Medtronic Perfusion Systems is recalling multiple arterial cannula models worldwide due to potential for unsealed sterile packing. Compromised packaging may allow contamination of devices intended for clinical use.