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U.S. Department of Health and Human Services

Medical Device Recalls
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Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll... 1 06/12/2026 FEI # 1220648
Abiomed, Inc.
Atlan A350. Model Number: 8211500. anesthesia workstation 1 06/04/2026 FEI # 2517967
Draeger, Inc.
Atlan A350XL. Model Number: 8621600. anesthesia workstation 1 06/04/2026 FEI # 2517967
Draeger, Inc.
Pediatric care bed; Product Designation: KayserBett IDA; 1 06/04/2026 FEI # 3006795806
KAYSERBETTEN GMBH & CO. KG
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x ... 1 06/03/2026 FEI # 2521402
B Braun Medical Inc
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material... 1 06/03/2026 FEI # 2521402
B Braun Medical Inc
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRA... 1 06/03/2026 FEI # 2521402
B Braun Medical Inc
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. 1 06/03/2026 FEI # 3014732157
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 1 05/29/2026 FEI # 3014732157
Fresenius Kabi USA, LLC
BD®Spinal Tray with BD®Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.7... 1 05/29/2026 FEI # 2243072
Becton Dickinson & Company

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