FDA Device recall Z-2770-2026
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT by Penumbra, citing due to manufacturing issues, reperfusion catheters may fractures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2770-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-03 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Penumbra |
| Distribution | US |
Product
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Reason
Due to manufacturing issues, reperfusion catheters may fractures
Identifiers
| code_info | UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038 |
|---|
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-2770-2026%22
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