FDA Device recall Z-2219-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913
- FDA Device
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913 by Medtronic Perfusion Systems, citing certain lots of product have the potential for a sterile barrier breach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2219-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Reason
Certain lots of product have the potential for a sterile barrier breach.
Identifiers
| code_info | GTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262,…GTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2219-2026%22
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