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U.S. Department of Health and Human Services

Medical Device Recalls

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ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzym... 3 07/06/2021 FEI # 3000303338
Sentinel CH SpA
inLight Medical LED Pads used with Polychromatic light technology system 3 06/24/2021 FEI # 3010709091
Inlightened Partners LLC
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to b... 3 06/07/2021 FEI # 3013556777
MICROVENTION INC.
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to b... 3 06/07/2021 FEI # 3013556777
MICROVENTION INC.
VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to b... 3 06/07/2021 FEI # 3013556777
MICROVENTION INC.
VenaSeal Closure System 3 05/12/2021 FEI # 2183870
Medtronic Inc.
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provid... 3 04/28/2021 FEI # 3001418283
Datascope Corp.
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provid... 3 04/28/2021 FEI # 3001418283
Datascope Corp.
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic... 3 04/26/2021 FEI # 3005099803
Boston Scientific Corporation
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Viny... 3 04/10/2021 FEI # 1000160256
OriGen Biomedical, Inc.

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