Recall Z-2770-2026— Penumbra, Inc.

Name: FDA recall Z-2770-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-03

Class II · Ongoing

Class II FDA medical device recall by Penumbra, Inc., initiated 2026-06-03. It names one FDA 510(k) clearance: K211411. Product: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT. Reason: Due to manufacturing issues, reperfusion catheters may fractures.

Recalling firm: Penumbra, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-06-03
Firm location: Livermore, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K211411 — Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.·cleared 2021-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Reason for recall

Due to manufacturing issues, reperfusion catheters may fractures

Data sourced from openFDA. This site is unofficial and independent of the FDA.