FDAFDA · Food and drugs·Recall number Z-3331-2026
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
Published October 7, 2026 · Recall initiated: July 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to manufacturing issues reperfusion catheters may fracture.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Penumbra Inc.
- Distributor
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
- Lot
- Lot Code: UDI: 00815948024359 Lot Number: H00007856
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Related recalls
- FDABrand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Numbe…October 7, 2026
- FDASystems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: …October 7, 2026
- FDAOlympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction w…October 7, 2026
- FDAHOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II te…October 7, 2026
- FDABrand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Cat…October 7, 2026
- FDACHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating SystemOctober 7, 2026
- FDABrand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/C…October 7, 2026
- FDAPenumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acut…July 26, 2017
Questions about this recall
Was 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 recalled?
Yes. FDA published recall Z-3331-2026 on October 7, 2026. Reported hazard: Due to manufacturing issues reperfusion catheters may fracture.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.