What was recalled and why?

Medtronic Perfusion Systems recalled Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter. FDA's record states the reason for recall as: Certain lots of product have the potential for a sterile barrier breach.. The recall is logged under FDA recall number Z-2221-2026 with a Class II classification.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter) and recall number Z-2221-2026, then follow Medtronic Perfusion Systems's recall instructions.

Has Medtronic Perfusion Systems had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 12 total FDA actions tied to Medtronic Perfusion Systems, including 12 recalls and 0 warning letters.

FDA Class II Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR,… by Medtronic Perfusion Systems

Key facts

Recalling firm	Medtronic Perfusion Systems
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Classification	Class II
Recall number	Z-2221-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Certain lots of product have the potential for a sterile barrier breach.

In short: Medtronic Perfusion Systems recalled Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter on 2026-05-27. FDA classified this action as a Class II recall (recall number Z-2221-2026). Reason for recall: Certain lots of product have the potential for a sterile barrier breach.. Recall status: Ongoing. This is a device-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter -- and the recall number Z-2221-2026. If it matches, stop using or distributing it and contact Medtronic Perfusion Systems or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Medtronic Perfusion Systems and the affected product is described in FDA's record as: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter. FDA's stated reason for the recall is: Certain lots of product have the potential for a sterile barrier breach.. The recall is tracked under FDA recall number Z-2221-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

Medtronic Perfusion Systems’s FDA history

Argus HQ has recorded 12 total FDA actions tied to Medtronic Perfusion Systems: 0 warning letters, 12 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: Medtronic Perfusion Systems recalled Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter. FDA's record states the reason for recall as: Certain lots of product have the potential for a sterile barrier breach.. The recall is logged under FDA recall number Z-2221-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter) and recall number Z-2221-2026, then follow Medtronic Perfusion Systems's recall instructions.
Has Medtronic Perfusion Systems had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 12 total FDA actions tied to Medtronic Perfusion Systems, including 12 recalls and 0 warning letters.

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Full FDA history for Medtronic Perfusion Systems

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR,… by Medtronic Perfusion Systems. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-medtronic-perfusion-systems-z-2221-2026

MLA

"FDA Class II Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR,… by Medtronic Perfusion Systems." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-medtronic-perfusion-systems-z-2221-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR,… by Medtronic Perfusion Systems." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-medtronic-perfusion-systems-z-2221-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_medtronic_perfusion_systems_z_2221_2026_2026,
  title = {FDA Class II Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR,… by Medtronic Perfusion Systems},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-medtronic-perfusion-systems-z-2221-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗