Penumbra recall: System
Penumbra Inc. is recalling Penumbra System – 43. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on July 24, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Penumbra System |
| Brand | Penumbra |
| Company | Penumbra Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 24, 2026 |
| Published by FDA | October 7, 2026 |
| Quantity | 43 |
| Recall ID | 99591 |
Recalled products
- 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
- FDA recall number
- Z-3331-2026
- Codes, lots and dates
- Lot Code: UDI: 00815948024359 Lot Number: H00007856
- Quantity
- 43
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99591
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Alameda, CA, United States
Why it was recalled
The reason the FDA lists: “Due to manufacturing issues reperfusion catheters may fracture.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99591, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Penumbra Penumbra System recalled?
Yes. Penumbra Inc. recalled it on July 24, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Due to manufacturing issues reperfusion catheters may fracture.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.