FDA Device recall Z-2221-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915
- 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 15FR, Model 94915 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-2221-2026 |
| 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 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Reason
Certain lots of product have the potential for a sterile barrier breach.
Identifiers
| code_info | GTIN 20643169454808, Lot Numbers: 0231859673. |
|---|
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-2221-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.