Penumbra RED 68 Reperfusion Catheter Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Penumbra, Inc. is recalling the Penumbra System RED 68 Reperfusion Catheter due to potential fractures from manufacturing issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Due to manufacturing issues, reperfusion catheters may fracture.
Which Products Are Affected
Penumbra System RED 68 Reperfusion Catheter, REF: RED68KIT, UDI: 00815948024113. Affected lots: H00008699, H00008701, H00008702, H00008703, and C00020038. Distributed worldwide including US nationwide in 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. Recall number Z-2770-2026. Classification: Class II. Initiated June 3, 2026.
What You Should Do
This is a voluntary firm-initiated recall notified by letter.
Why This Matters
The Class II recall involves reperfusion catheters distributed across the United States and multiple international markets.
Source
FDA recall Z-2770-2026, report date July 29, 2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,011 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.