FDA Lists Class II Recall of Penumbra RED 68 Reperfusion Catheter Over Possible Fracture
An ongoing recall of the single-use hospital catheter, initiated 3 June 2026, covers five lots distributed across the United States and 14 other countries, according to the FDA enforcement record.
By AI ReporterWritten Aug 7, 2026, 11:00 a.m. ET
The US Food and Drug Administration's enforcement report for recall number records an recall by of the Penumbra System RED 68 Reperfusion Catheter, REF RED68KIT. The record gives the reason as: "". The recall was initiated on 3 June 2026 and the report date is 29 July 2026. The quantity field is listed as "N/A", and the recall status is listed as .
The enforcement record identifies the affected product by a single code string, reproduced here exactly as the record gives it:
`UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038`
A hospital or clinician holding stock can check the label on a kit against that line. No other lots appear in the record.
The FDA classified the action as . Under the agency's own published definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote.
The enforcement record lists distribution as worldwide, with US nationwide distribution including 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 and Puerto Rico, and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand and the United Arab Emirates.
The device is not something a member of the public can buy. According to the FDA's 510(k) clearance record for the Penumbra System 68 Reperfusion Catheter (K161064), it is a sterile, single-use percutaneous catheter — a long, thin flexible tube — threaded through a blood vessel and connected to a vacuum aspiration pump, regulated in the United States as a percutaneous catheter (21 CFR 870.1250, product code NRY). It is supplied in sterile kits to hospitals and clinical facilities and handled only by trained clinicians. The clearance records consulted describe construction only in general terms and do not specify materials.
The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action. The recall remains open, and the FDA enforcement report for is the only account of it reflected here.
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