Class I medical devices recalls – page 6

• BD Alaris infusion Pump Module 8100 recall
  FDA November 26, 2025 · CareFusion 303, Inc. · Class I
• Convenience kits recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Convenience kits recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Anesthesia circuit kit recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY… recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Convenience Kit, BREAST HERNIA DYNJ909125G recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D… recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia… recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia… recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia… recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• Anesthesia Circuit Kits and other various kits that contain Anesthesia… recall
  FDA November 19, 2025 · Medline Industries, LP · Class I
• CEREPAK Detachable Coil System - Name recall
  FDA November 19, 2025 · Cerenovus Inc · Class I
• MAGNETOM Cima.X Upgrade recall
  FDA November 19, 2025 · Siemens Medical Solutions USA, Inc · Class I
• Tandem Mobi Insulin Pump: Description recall
  FDA November 12, 2025 · Tandem Diabetes Care, Inc. · Class I
• CODMAN Disposable Perforator 9mm recall
  FDA November 12, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• CODMAN Disposable Perforator 11mm recall
  FDA November 12, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and… recall
  FDA November 5, 2025 · Dexcom, Inc. · Class I
• MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model recall
  FDA November 5, 2025 · Balt USA, LLC · Class I
• IMRIS Operating Suite, InVision 3T Operating Suite… recall
  FDA November 5, 2025 · IMPRIS Imaging Inc · Class I
• IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI… recall
  FDA November 5, 2025 · IMPRIS Imaging Inc · Class I
• IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet… recall
  FDA November 5, 2025 · IMPRIS Imaging Inc · Class I
• IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System… recall
  FDA November 5, 2025 · IMPRIS Imaging Inc · Class I
• IV Administration sets recall
  FDA October 29, 2025 · ICU Medical, Inc. · Class I
• Automated Impella Controller (AIC) labeled as the following with… recall
  FDA October 29, 2025 · Abiomed, Inc. · Class I
• Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG… recall
  FDA October 29, 2025 · B Braun Medical Inc · Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F) recall
  FDA October 22, 2025 · Abbott · Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J) recall
  FDA October 22, 2025 · Abbott · Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F) recall
  FDA October 22, 2025 · Abbott · Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D) recall
  FDA October 22, 2025 · Abbott · Class I
• TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D) recall
  FDA October 22, 2025 · Abbott · Class I
• Model Number U228, VISIONIST CRT-P EL MRI recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U226, VISIONIST CRT-P EL recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U225 VISIONIST CRT-P EL recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U128, VALITUDE CRT-P EL MRI recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U125, VALITUDE CRT-P EL recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number S722, ALTRUA 2 DR EL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number S702, ALTRUA 2 DR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number S701 ALTRUA 2 SR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L131, ESSENTIO DR EL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L121 ESSENTIO DR EL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L111, ESSENTIO DR SL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L110, ESSENTIO SR SL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L101, ESSENTIO DR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L100, ESSENTIO SR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L231, PROPONENT DR EL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L221 PROPONENT DR EL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L211 PROPONENT DR SL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L210 PROPONENT SR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L209 PROPONENT DR (VDD) SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• PROPONENT DR SL (Model L201) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• PROPONENT SR SL (Model L200) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR EL MRI (Model L331) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR EL (Model L321) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR SL MRI (Model L311) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE SR SL MRI (Model L310) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR SL (Model L301) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE SR SL (Model L300) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 recall
  FDA October 22, 2025 · Olympus Corporation of the Americas · Class I
• EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 recall
  FDA October 22, 2025 · Olympus Corporation of the Americas · Class I
• EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 recall
  FDA October 22, 2025 · Olympus Corporation of the Americas · Class I