Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94725) due to potential sterile barrier breach. Affected units may pose infection risks during medical procedures.
Certain lots of product have the potential for a sterile barrier breach.
Medtronic is recalling certain lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94725) because they may have a sterile barrier breach. This could lead to infection risks during medical procedures if used improperly.
The sterile barrier breach could allow contaminants to enter the bloodstream during surgery, potentially causing infections. This risk is specific to medical procedures involving the cardiovascular system.
Patients undergoing cardiopulmonary bypass surgery who use this specific cannula model are most at risk. Healthcare providers using the recalled lots during procedures may also be affected.
Check for the model number 94725 on the silicone body. Look for lot numbers listed: 0231650787, 0231758255, 0231862812, C231966207, and others as specified in the recall notice.
Identify the model number (94725) and lot numbers listed in the recall notice to confirm if your device is affected.
The recall specifies that certain lots have a potential for sterile barrier breach, so affected units should not be used until the remedy is applied.
The recall does not specify a remedy, so contact Medtronic directly to determine next steps for affected units.
Check for the model number 94725 and lot numbers listed: 0231650787, 0231758255, 0231862812, C231966207, and others as specified in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2218-2026 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2218-2026 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.