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U.S. Department of Health and Human Services

Medical Device Recalls
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RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-1... 1 05/22/2026 FEI # 1000135961
Bolton Medical Inc.
Automated Impella Controller (AIC); Product Code: 0042-0000-US; 1 05/22/2026 FEI # 1220648
Abiomed, Inc.
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-... 1 05/13/2026 FEI # 3013162291
ARROW INTERNATIONAL, LLC
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, C... 1 05/13/2026 FEI # 3013162291
ARROW INTERNATIONAL, LLC
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, A... 1 05/13/2026 FEI # 3013162291
ARROW INTERNATIONAL, LLC
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I 1 05/13/2026 FEI # 3013162291
ARROW INTERNATIONAL, LLC
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERI... 1 05/13/2026 FEI # 3007880912
Omnicell, Inc.
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT... 1 05/08/2026 FEI # 1417592
Medline Industries, LP
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medlin... 1 05/08/2026 FEI # 1417592
Medline Industries, LP
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number:... 1 05/08/2026 FEI # 1417592
Medline Industries, LP

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