# FDA recall Z-2770-2026

> **Penumbra, Inc.** · Class II · device recall initiated 2026-06-03.

## Product

Penumbra System RED 68 Reperfusion Catheter  REF: RED68KIT

## Reason for recall

Due to manufacturing issues,  reperfusion catheters may fractures

## 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.

## Key facts

- **Recall number:** Z-2770-2026
- **Recalling firm:** Penumbra, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-03
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livermore, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2770-2026

## Citation

> AI Analytics. FDA recall Z-2770-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2770-2026. Source: US FDA. Licensed CC0.

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