Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT — Class II medical device recall Z-2770-2026
Ongoing recall by Penumbra, Inc., reported 2026-07-29, distributed nationwide. Due to manufacturing issues, reperfusion catheters may fractures
| Recall number | Z-2770-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Penumbra, Inc., Livermore, CA, United States |
| Recall initiated | 2026-06-03 |
| Classified | 2026-07-21 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BR, CA, CO, EC, ID, IL, LB, MX, PH, SA, TH |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00815948024113 |
| Lot numbers | C00020038, H00008699, H00008701, H00008702, H00008703 |
| Model numbers | RED68KIT |
Product
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Reason for recall
Due to manufacturing issues, reperfusion catheters may fractures
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2770-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.