Medical Device Recalls

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Class 1 Recall Date from: 01/01/2022 Recall Date to: 12/31/2022

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Product Description	Recall Class	FDA Recall Posting Date	Recalling Firm
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Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is inten...	1	03/18/2022	FEI # 2518422 Philips Respironics, Inc.
Cub 2 Enclosed Bed Canopy System	1	04/14/2022	FEI # 3016541541 Sensory Medical Inc
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replaceme...	1	04/18/2022	FEI # 3001504994 Medtronic Inc
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)	1	04/18/2022	FEI # 2518422 Respironics California, LLC
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outs...	1	04/18/2022	FEI # 2518422 Respironics California, LLC
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 10536...	1	04/18/2022	FEI # 2518422 Respironics California, LLC
Puritan Bennett 980 Series Ventilator	1	04/25/2022	FEI # 3002807850 Medtronic formerly Covidien
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02	1	04/27/2022	FEI # 3015423092 CELLTRION USA INC
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test	1	05/03/2022	FEI # 3022161362 SML Distribution, LLC
Accula SARS-CoV-2 Test, REF: COV4100	1	05/06/2022	FEI # 3013026082 MESA BIOTECH, INC