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U.S. Department of Health and Human Services

Medical Device Recalls
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Product Description
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Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; O... 1 07/01/2026 FEI # 1417572
Baxter Healthcare Corporation
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M084... 1 07/01/2026 FEI # 1417572
Baxter Healthcare Corporation
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-5... 1 06/30/2026 FEI # 3014585508
Insulet Corporation
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-622... 1 06/30/2026 FEI # 3014585508
Insulet Corporation
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (... 1 06/30/2026 FEI # 3014585508
Insulet Corporation
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-... 1 06/30/2026 FEI # 3014766741
Hamilton Medical AG
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. ... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. ... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.

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