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Penumbra System (RED 62 Reperfusion Catheter)

Official notice

7 Oct 2026

Last checked

13 Oct 2026

MediumFDA

An official FDA notice concerns Penumbra. The notice reports an injury risk. Stop using the product and follow the official notice. Published 2026-10-07. Lots: H00007856, UDI. Recall numbers: Z-3331-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

43

Recall number

Z-3331-2026

Official notice

2026-10-07

The hazard

Injury risk

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

H00007856, UDI

Event Ids

99591

Recall Numbers

Z-3331-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Penumbra. Contact: Penumbra Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3331-2026

Event id

99591

Units affected

43

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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Brand match

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Markets

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