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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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Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Numb... 1 06/24/2026 FEI # 1417592
Medline Industries, LP
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ9055... 1 06/24/2026 FEI # 1417592
Medline Industries, LP
Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL... 1 06/24/2026 FEI # 1417592
Medline Industries, LP
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEAR... 1 06/24/2026 FEI # 1417592
Medline Industries, LP
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if ... 1 06/18/2026 FEI # 3036470679
Datex-Ohmeda Inc
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitati... 1 06/18/2026 FEI # 3036470679
Datex-Ohmeda Inc
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Produc... 1 06/18/2026 FEI # 3036470679
Datex-Ohmeda Inc
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. 1 06/18/2026 FEI # 1220648
Abiomed, Inc.
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU 1 06/13/2026 FEI # 3013162291
ARROW INTERNATIONAL, LLC
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI... 1 06/13/2026 FEI # 3013162291
ARROW INTERNATIONAL, LLC

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