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U.S. Department of Health and Human Services

Medical Device Recalls

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Impella RP with SmartAssist; Product Number: 0046-0035; 1 01/15/2025 Abiomed, Inc.
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube. 1 01/10/2025 Trokamed GmbH
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube. 1 01/10/2025 Trokamed GmbH
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. 1 01/10/2025 Trokamed GmbH
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. 1 01/10/2025 Trokamed GmbH
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1... 1 01/10/2025 Mercury Enterprises, Inc. dba Mercury Medical
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), a... 1 01/10/2025 Boston Scientific Corporation
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L... 1 01/10/2025 Boston Scientific Corporation
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), an... 1 01/10/2025 Boston Scientific Corporation
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) 1 01/10/2025 Boston Scientific Corporation

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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