CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
System RED 68 Reperfusion Catheter recalled by Penumbra
Penumbra is recalling Penumbra System RED 68 Reperfusion Catheter, distributed nationwide in the US. The recall was initiated on 3 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2770-2026
- FDA event ID
- 99148
- Recalling firm
- Penumbra, Livermore, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jun 2026
- FDA classified
- 21 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 Jun 2026 | Recall initiated by company | |
| 21 Jul 2026 | Classified by FDA | +48 days |
| 29 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing issues, reperfusion catheters may fractures
Product as listed by the FDA
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Where it was distributed
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.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Is System RED 68 Reperfusion Catheter recalled?
Yes. Penumbra recalled System RED 68 Reperfusion Catheter on 3 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2770-2026.
Why was it recalled?
Due to manufacturing issues, reperfusion catheters may fractures
Which lots are affected?
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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