FDA
Food and Drug Administration · Recall Z-2770-2026 · Jun 3, 2026Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc.
The hazard
Due to manufacturing issues, reperfusion catheters may fractures FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: 00815948024113/Lots: H00008699Model H00008701Model H00008702Model H00008703Model and C00020038UPC 00815948024113Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.