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U.S. Department of Health and Human Services

Medical Device Recalls
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Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator devi... 1 04/02/2026 FEI # 2518422
Philips Respironics, Inc.
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.... 1 04/02/2026 FEI # 2518422
Philips Respironics, Inc.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devic... 1 04/02/2026 FEI # 2518422
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilat... 1 04/02/2026 FEI # 2518422
Philips Respironics, Inc.
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxte... 1 04/01/2026 FEI # 1417572
Baxter Healthcare Corporation
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in ... 1 03/31/2026 FEI # 1220648
Abiomed, Inc.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1... 1 03/27/2026 FEI # 1220648
Abiomed, Inc.
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H... 1 03/26/2026 FEI # 1721504
Merit Medical Systems, Inc.
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871... 1 03/26/2026 FEI # 1721504
Merit Medical Systems, Inc.
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B 1 03/26/2026 FEI # 1721504
Merit Medical Systems, Inc.

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