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U.S. Department of Health and Human Services

Medical Device Recalls

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NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions:... 1 07/24/2024 Medtronic Xomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump 1 07/17/2024 Abiomed, Inc.
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit... 1 07/17/2024 Baxter Healthcare Corporation
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device comp... 1 07/17/2024 Baxter Healthcare Corporation
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injecti... 1 07/11/2024 Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal inje... 1 07/11/2024 Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravi... 1 07/11/2024 Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye) 1 07/11/2024 Synergetics Inc
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEG... 1 07/03/2024 Megadyne Medical Products, Inc.
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patien... 1 07/03/2024 Megadyne Medical Products, Inc.

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