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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Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO	1	05/19/2022	FEI # 2024168 Abbott Vascular
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System cons...	1	02/03/2022	FEI # 1220648 Abiomed, Inc.
Clean Catch Urine Kit NS 178489, AHMU58A	1	07/01/2022	FEI # 3003419114 American Contract Systems, Inc.
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184...	1	07/01/2022	FEI # 3003419114 American Contract Systems, Inc.
Sara Plus Active Floor Lift	1	05/21/2022	FEI # 3007420694 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump	1	12/15/2022	FEI # 3013162291 ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), ...	1	12/15/2022	FEI # 3013162291 ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), ca...	1	12/15/2022	FEI # 3013162291 ARROW INTERNATIONAL Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), ...	1	12/15/2022	FEI # 3013162291 ARROW INTERNATIONAL Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump	1	12/15/2022	FEI # 3013162291 ARROW INTERNATIONAL Inc.