Recall Atlas

Penumbra recalls

2 official recalls and safety alerts involving Penumbra since 2026-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Penumbra or the relevant agency.

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog…

    Due to manufacturing issues reperfusion catheters may fracture.

    FDA · DevicePenumbra Inc.US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX,…Official notice →
  3. 2026-07-29
  4. US
    Drugs & medicalClass II

    Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

    Due to manufacturing issues, reperfusion catheters may fractures

    FDA · DevicePenumbra, Inc.Worldwide - US Nationwide distribution including in the states and territories…Official notice →