Class I medical devices recalls – page 8

• DLP Left Heart Vent Catheter Malleable body and vented connector… recall
  FDA September 10, 2025 · Medtronic Perfusion Systems · Class I
• DLP Left Heart Vent Catheter Malleable body and vented connector… recall
  FDA September 10, 2025 · Medtronic Perfusion Systems · Class I
• IDM-ARLITE-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• All-round Joystick R-net Light recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• IDM-MULTI-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• IDM-MICRO-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Multi Joystick R-net recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Micro Joystick R-net recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• WATCHMAN TruSteer Access System, US, Material Number (UPN)… recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump recall
  FDA September 10, 2025 · Baxter Healthcare Corporation · Class I
• Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump recall
  FDA September 10, 2025 · Baxter Healthcare Corporation · Class I
• Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump recall
  FDA September 10, 2025 · Baxter Healthcare Corporation · Class I
• Medline ReNewal Reprocessed St recall
  FDA September 3, 2025 · Medline Industries, LP · Class I
• Battery Operated infusion pumps recall
  FDA September 3, 2025 · Tandem Diabetes Care, Inc. · Class I
• Hamilton C6 recall
  FDA August 27, 2025 · Hamilton Medical AG · Class I
• RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense… recall
  FDA August 27, 2025 · Boston Scientific Corporation · Class I
• ENDOTAK RELIANCE G/SG with 4-SITE Connector… recall
  FDA August 27, 2025 · Boston Scientific Corporation · Class I
• ENDOTAK RELIANCE G/SG, transvenous defibrillation lead… recall
  FDA August 27, 2025 · Boston Scientific Corporation · Class I
• HeartMate Product Name: Mobile Power Unit Model recall
  FDA August 20, 2025 · Thoratec LLC · Class I
• HeartMate Product Name: Mobile Power Unit, AC Power Cord Model recall
  FDA August 20, 2025 · Thoratec LLC · Class I
• Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding… recall
  FDA August 20, 2025 · Boston Scientific Corporation · Class I
• DreamStation Auto recall
  FDA August 20, 2025 · Philips Respironics, Inc. · Class I
• DreamStation Auto BiPAP. Non-Continuous Ventilator recall
  FDA August 20, 2025 · Philips Respironics, Inc. · Class I
• DreamStation Auto CPAP. Non-Continuous Ventilator recall
  FDA August 20, 2025 · Philips Respironics, Inc. · Class I
• Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult recall
  FDA August 20, 2025 · Ambu · Class I
• Baxter Novum IQ Large Volume Pump, Product Code recall
  FDA August 20, 2025 · Baxter Healthcare Corporation · Class I
• BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU… recall
  FDA August 13, 2025 · Flexicare Medical (Dongguan) Ltd. · Class I
• BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle recall
  FDA August 13, 2025 · Flexicare Medical (Dongguan) Ltd. · Class I
• Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle recall
  FDA August 13, 2025 · Flexicare Medical (Dongguan) Ltd. · Class I
• BritePro Solo Mini with Pro Miller Blade Size 1.5 recall
  FDA August 13, 2025 · Flexicare Medical (Dongguan) Ltd. · Class I
• BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac… recall
  FDA August 13, 2025 · Flexicare Medical (Dongguan) Ltd. · Class I
• BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref:… recall
  FDA August 13, 2025 · Flexicare Medical (Dongguan) Ltd. · Class I
• BD Alaris Pump Infusion Sets recall
  FDA August 13, 2025 · CareFusion 303, Inc. · Class I
• BD Alaris Pump Module Model, 8100 with Guardrails… recall
  FDA August 13, 2025 · CareFusion 303, Inc. · Class I
• Microbore Extension Set with 0.2 Micron Filter recall
  FDA August 13, 2025 · B Braun Medical Inc · Class I
• Plum Duo Infusion System, List Number: 400020401 recall
  FDA August 13, 2025 · ICU Medical, Inc. · Class I
• Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory… recall
  FDA August 6, 2025 · Hamilton Medical AG · Class I
• Automated Impella Controller (AIC), used in left heart support blood pump… recall
  FDA August 6, 2025 · Abiomed, Inc. · Class I
• SafeStar 60A Plus Filter recall
  FDA August 6, 2025 · Draeger, Inc. · Class I
• HME TwinStar HEPA Plus Filter recall
  FDA August 6, 2025 · Draeger, Inc. · Class I
• SafeStar 55 Plus Filter recall
  FDA August 6, 2025 · Draeger, Inc. · Class I
• SafeStar 90 Plus Filter recall
  FDA August 6, 2025 · Draeger, Inc. · Class I
• i-view video laryngoscope recall
  FDA July 23, 2025 · Intersurgical Inc · Class I
• Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 recall
  FDA July 23, 2025 · Baxter Healthcare Corporation · Class I
• Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX recall
  FDA July 23, 2025 · Baxter Healthcare Corporation · Class I