Use cautionMedical device recall · FDA · Published June 3, 2026
Penumbra RED 68 Reperfusion Catheter Recall: Fracture Risk
Penumbra recalls RED 68 Reperfusion Catheters with potential fracture risk due to manufacturing issues. Affected units include specific UDI and lot numbers.
“Penumbra RED 68 Reperfusion Catheter Recall: Fracture Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127844-penumbra-red-68-reperfusion-catheter-recall-fracture-risk. Based on FDA recall #Z-2770-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2770-2026%22&limit=1).
The FDA announced on June 3, 2026, that Penumbra Inc. is recalling the Penumbra System RED 68 Reperfusion Catheter due to manufacturing issues that may cause the catheters to fracture.
How to tell if you have it
Brand: Penumbra
Product: Penumbra System RED 68 Reperfusion Catheter
REF: RED68KIT
UDI: 00815948024113
Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
The hazard
According to the FDA, manufacturing issues may cause the reperfusion catheters to fracture.
Context
GovInfoNow's records show Penumbra Inc. has issued three other recalls since June 9, 2017. Other recent recalls of similar products include Medline Urethral Catheter Tray Recall (May 4, 2026), Bard PowerPICC Catheters Recall (May 21, 2026), and Medline ViewFlex Xtra ICE Catheters Recall (Dec. 22, 2025).
How to tell if you have this one
Check for the UDI code 00815948024113 and lot numbers H00008699, H00008701, H00008702, H00008703, or C00020038 on the catheter packaging or label.
Brand
Penumbra
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Fracture Risk
Inspect the catheter for signs of fracture or damage before use. If fractured, stop using it immediately.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 36 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2770-2026 (June 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2770-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.