Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3331-2026%22

Class II recall Z-3331-2026: Penumbra Inc.

Q: How to monitor Class II recall Z-3331-2026: Penumbra Inc. and peer other records

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Class II recall Z-3331-2026: Penumbra Inc. (California): Penumbra Inc. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-3331-2026
Recalling firm	Penumbra Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62). Component: Penumbra System
Reason	Due to manufacturing issues reperfusion catheters may fracture.
Quantity	43
Distribution	US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Recall initiated	2026-07-24
Reported	2026-10-07
Firm location	Alameda, CA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-07
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-3331-2026: Penumbra Inc. and 76 California peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

California FDAPulse records like this one: 76
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 28 days ago.

What is the FDAPulse record for Class II recall Z-3331-2026: Penumbra Inc. in California?

Class II device recall Z-3331-2026 by Penumbra Inc.: Due to manufacturing issues reperfusion catheters may fracture.

How does Class II recall Z-3331-2026: Penumbra Inc. compare to other California FDAPulse records?

It is 28 days old, still within a typical 45-day follow-up window.

Class II recall Z-3331-2026 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-3331-2026	CA	2026-10-07
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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