Penumbra, Inc. Recalls

Overview of recall records associated with Penumbra, Inc., including dates, categories and classifications where available.

1recall records

Jul 29, 2026latest record date

Jul 29, 2026earliest record date

Recall history in this database

Classification mix: Class II: 1.

Medical DeviceJul 29, 2026

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall — FDA Z-2770-2026

Due to manufacturing issues, reperfusion catheters may fractures

Class IIFDA: OngoingPenumbra, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Penumbra, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.