Class I medical devices recalls – page 4

• Halyard PERC TRAY kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• Halyard NEURO IR PERIPHERAL (PS 64405) kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• Halyard HEART CATH, SELF REGIONAL kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• Halyard CATH LAB kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• Halyard CATH LAB kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• Halyard CARDIAC CATH TRAY SHANDS JAX kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• Halyard CARDIAC CATH PACK SAN23CARDQ kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• Halyard CARDIAC CATH PACK kit recall
  FDA May 13, 2026 · AVID Medical, Inc. · Class I
• VOCSN V+Pro package recall
  FDA May 13, 2026 · Ventec Life Systems, Inc. · Class I
• Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20… recall
  FDA May 13, 2026 · Cook Incorporated · Class I
• Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN… recall
  FDA May 13, 2026 · Cook Incorporated · Class I
• Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916… recall
  FDA May 13, 2026 · Cook Incorporated · Class I
• Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and… recall
  FDA May 13, 2026 · Intuitive Surgical, Inc. · Class I
• AIDBAGs are first aid kits of convenience composed of individually labeled… recall
  FDA May 6, 2026 · North American Rescue LLC. · Class I
• WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05 recall
  FDA May 6, 2026 · Whill, Inc. · Class I
• WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13 recall
  FDA May 6, 2026 · Whill, Inc. · Class I
• Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1… recall
  FDA May 6, 2026 · Boston Scientific Corporation · Class I
• Boston Scientific Pacemaker, Implantable Pulse Generator… recall
  FDA May 6, 2026 · Boston Scientific Corporation · Class I
• B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT… recall
  FDA April 22, 2026 · B Braun Medical Inc · Class I
• B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT… recall
  FDA April 22, 2026 · B Braun Medical Inc · Class I
• B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC… recall
  FDA April 22, 2026 · B Braun Medical Inc · Class I
• B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA… recall
  FDA April 22, 2026 · B Braun Medical Inc · Class I
• B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG… recall
  FDA April 22, 2026 · B Braun Medical Inc · Class I
• B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR… recall
  FDA April 22, 2026 · B Braun Medical Inc · Class I
• Omnipod 5 Pods recall
  FDA April 22, 2026 · Insulet Corporation · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• NAMIC Angiographic Syringe, labeled as follows: 1… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• NAMIC Angiographic Syringe, labeled as follows: 1… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• NAMIC Angiographic Control Syringe, labeled as follows: 1… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• NAMIC Angiographic Syringe, labeled as follows: 1… recall
  FDA April 15, 2026 · Medline Industries, LP · Class I
• Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00… recall
  FDA April 8, 2026 · Philips Respironics, Inc. · Class I
• Philips Respironics Trilogy EV300, Software Version 1.05.15.00… recall
  FDA April 8, 2026 · Philips Respironics, Inc. · Class I
• Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00… recall
  FDA April 8, 2026 · Philips Respironics, Inc. · Class I
• Philips Respironics Trilogy Evo, Software Version 1.05.15.00… recall
  FDA April 8, 2026 · Philips Respironics, Inc. · Class I
• Blue Ventilator Adapter Module, single-patient use circuit… recall
  FDA April 8, 2026 · Baxter Healthcare Corporation · Class I
• Automated Impella Controller (AIC), labeled as the following with… recall
  FDA April 8, 2026 · Abiomed, Inc. · Class I
• Purge Cassette, sold within Impella Pump Sets and Individually Packaged recall
  FDA April 8, 2026 · Abiomed, Inc. · Class I
• Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00… recall
  FDA April 1, 2026 · Philips Respironics, Inc. · Class I
• Philips Respironics Trilogy EV300, Software Version 1.05.15.00… recall
  FDA April 1, 2026 · Philips Respironics, Inc. · Class I
• Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00… recall
  FDA April 1, 2026 · Philips Respironics, Inc. · Class I
• Philips Respironics Trilogy Evo, Software Version 1.05.15.00… recall
  FDA April 1, 2026 · Philips Respironics, Inc. · Class I
• Handy Solutions Neck & Shoulders Heating Pad, Number: 25607… recall
  FDA April 1, 2026 · Navajo Manufacturing Company · Class I
• BioFlo DuraMax Catheter recall
  FDA April 1, 2026 · Merit Medical Systems, Inc. · Class I
• DuraMax Chronic Hemodialysis Catheter recall
  FDA April 1, 2026 · Merit Medical Systems, Inc. · Class I
• 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile) recall
  FDA April 1, 2026 · Merit Medical Systems, Inc. · Class I
• ProGuide Chronic Dialysis Catheters recall
  FDA April 1, 2026 · Merit Medical Systems, Inc. · Class I