RecallReported October 7, 2026
Class II recall by Penumbra Inc.
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: …
FDA's enforcement report of October 7, 2026 lists a Class II recall by Penumbra Inc. of Alameda, CA. Product: Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: …. Status: Ongoing.
On the record
- Recalling firm
- Penumbra Inc.
- Location
- Alameda, CA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3331-2026
- Product type
- Devices
- Recall initiated
- 2026-07-24
- Reported by FDA
- 2026-10-07
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
More
Watch Penumbra Inc
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA enforcement reports. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Penumbra Inc.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.