FDA DeviceClass IINotable

FDA Recall: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Date: 2026-07-29
Brand: Penumbra, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to manufacturing issues, reperfusion catheters may fractures

Hazard

Due to manufacturing issues, reperfusion catheters may fractures

Remedy

N/A

View original recall →
Share:

Related Recalls

2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12
Windstone Medical Packaging, Inc.
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS
Windstone Medical Packaging, Inc.
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part
Windstone Medical Packaging, Inc.