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Penumbra
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Penumbra and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-29FDA-DeviceClass IIPenumbra RED 68 catheter recalled for fracture risk
Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.
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