PlainRecalls

Penumbra, Inc.

Compiled from official public sources by the publisher.

6 recalls on record · Latest: Jul 29, 2026

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Agency notice ledger

Federal filing book Penumbra, Inc. LIGHT-BOOK · SINGLE-AGENCY

#2,249 of 14,151 · 6 notices · 0.006% archive

  • BOOK 6 notices
  • RANK #2,249 of 14,151
  • SHARE 0.006% archive
  • AGENCY FDA Devices (6)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 29, 2026
  • PHOTO 1908 Brands

Nearest notice-volume peer: 1908 Brands (0 notice gap)

Penumbra, Inc. accounts for about 0.006% of the 104,423-notice archive on 6 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Penumbra, Inc.'s standing among 14,151 recalling firms

Penumbra, Inc. ranks 2,249th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Penumbra, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

6 2249th of 14151 higher than 11,804 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-15

Penumbra, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Penumbra, Inc. holds about 0.006% of archive notices alongside 6 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 29, 2026

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
FDA Devices Critical Jan 27, 2021

Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
FDA Devices Critical Jan 27, 2021

Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
FDA Devices Critical Jan 27, 2021

Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration System
FDA Devices Critical Jan 27, 2021

Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
FDA Devices Critical Jul 26, 2017

Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (6 here).

1908 Brands 6 Abbott Molecular 6 Advance Medical Designs, Inc. 6 Air Stream Corp. 6 Aire-Master of America Inc 6

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Abbott Molecular 6 Advance Medical Designs, Inc. 6 American Medical Systems, Inc. 6 Animas Corporation 6

Frequently Asked Questions

How many federal recall notices name Penumbra, Inc.? ▼
PlainRecalls indexes 6 distinct federal recall events naming Penumbra, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Penumbra, Inc. sit among other recalling firms? ▼
Penumbra, Inc. ranks #2,249 of 14,151 by distinct recall-event count among 14,151 firms in this archive (83rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Penumbra, Inc.'s notices? ▼
FDA Devices accounts for 6 of this firm's 6 indexed notices.
What product category dominates Penumbra, Inc.'s filing book? ▼
Filings for Penumbra, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Penumbra, Inc.: 6 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Penumbra, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026