FDAClass II · Medical device · Recall Z-2770-2026 · Recalled July 29, 2026

Penumbra System RED 68 Reperfusion Catheter REF recall — Penumbra, Inc.

Agency report date: July 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Penumbra System RED 68 Reperfusion Catheter REF
Company / brand: Penumbra
Lot / serial / date codes: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
Distribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.

Agency product description and boundaries

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Due to manufacturing issues, reperfusion catheters may fractures

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Penumbra System RED 68 Reperfusion Catheter REF

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2770-2026
Brand: Penumbra
Classification: Class II
Units affected: N/A
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Penumbra System RED 68 Reperfusion Catheter REF

Companies & origin

Recalling firm location: Livermore, CA, United States
Firm address: 6262 Patterson Pass Rd Ste A, N/A, 94550-9576

Identifying details (verbatim from the notice)

Product codes / lots: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
Distribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
Firm notified the public via: Letter
FDA event ID: 99148
Recall initiated: June 3, 2026
FDA classified: July 21, 2026
FDA report date: July 29, 2026

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 ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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