FDA Class II · Medical device · July 29, 2026
Penumbra System RED 68 Reperfusion Catheter REF recall — Penumbra, Inc.
Due to manufacturing issues, reperfusion catheters may fractures
Official ID Z-2770-2026 · Official record ↗
Penumbra recalls
Recall found. Penumbra is named in FDA Class II recall Z-2770-2026 covering Penumbra System RED 68 Reperfusion Catheter REF. Hazard: Due to manufacturing issues, reperfusion catheters may fractures Identifying details: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038. Status: Ongoing.
Models with recalls
All Penumbra recalls
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.