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U.S. Department of Health and Human Services

Medical Device Recalls
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Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or int... 1 07/28/2026 FEI # 3004604967
ResMed Ltd.
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), R... 2 07/28/2026 FEI # 3001503333
IsoTis OrthoBiologics, Inc.
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial r... 2 07/27/2026 FEI # 1000116158
Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass... 2 07/27/2026 FEI # 1000116158
Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass... 2 07/27/2026 FEI # 1000116158
Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a... 2 07/27/2026 FEI # 1000116158
Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a... 2 07/27/2026 FEI # 1000116158
Medtronic Perfusion Systems
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return ca... 2 07/27/2026 FEI # 1000116158
Medtronic Perfusion Systems
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 0087... 2 07/27/2026 FEI # 1000125955
Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, P... 2 07/27/2026 FEI # 1000125955
Windstone Medical Packaging, Inc.

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