Class I medical devices recalls – page 5

• CentrosFLO Hemodialysis Catheters recall
  FDA April 1, 2026 · Merit Medical Systems, Inc. · Class I
• Flexible Cryoprobe (OD 2.4mm, L1.15mm) recall
  FDA April 1, 2026 · Erbe USA Inc · Class I
• Flexible Cryoprobe (OD 1.7mm, L1.15mm) recall
  FDA April 1, 2026 · Erbe USA Inc · Class I
• Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) recall
  FDA April 1, 2026 · Erbe USA Inc · Class I
• Owner's Booklets and Instructions for Use that are used with the following… recall
  FDA March 18, 2026 · Trividia Health, Inc. · Class I
• Owner's Booklets and Instructions for Use that are used with the following… recall
  FDA March 18, 2026 · Trividia Health, Inc. · Class I
• Owner's Booklets and Instructions for Use that are used with the following… recall
  FDA March 18, 2026 · Trividia Health, Inc. · Class I
• Owner's Booklets and Instructions for Use that are used with the following… recall
  FDA March 18, 2026 · Trividia Health, Inc. · Class I
• Impella RP. Product Code: 0046-0011 recall
  FDA March 11, 2026 · Abiomed, Inc. · Class I
• Impella RP Flex with SmartAssist recall
  FDA March 11, 2026 · Abiomed, Inc. · Class I
• Impella RP with SmartAssist recall
  FDA March 11, 2026 · Abiomed, Inc. · Class I
• Olympus High Flow Insufflation Unit recall
  FDA February 25, 2026 · Olympus Corporation of the Americas · Class I
• Olympus High Flow Insufflation Unit recall
  FDA February 25, 2026 · Olympus Corporation of the Americas · Class I
• Olympus High Flow Insufflation Unit recall
  FDA February 25, 2026 · Olympus Corporation of the Americas · Class I
• Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON… recall
  FDA February 18, 2026 · Medline Industries, LP · Class I
• Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound… recall
  FDA February 18, 2026 · Medline Industries, LP · Class I
• Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE… recall
  FDA February 18, 2026 · Medline Industries, LP · Class I
• Reprocessed St recall
  FDA February 18, 2026 · Medline Industries, LP · Class I
• Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters:… recall
  FDA February 18, 2026 · Medline Industries, LP · Class I
• Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry… recall
  FDA February 18, 2026 · Medline Industries, LP · Class I
• Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10… recall
  FDA February 18, 2026 · Medline Industries, LP · Class I
• *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm recall
  FDA February 11, 2026 · Boston Scientific Corporation · Class I
• *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm recall
  FDA February 11, 2026 · Boston Scientific Corporation · Class I
• HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm recall
  FDA February 11, 2026 · Boston Scientific Corporation · Class I
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm recall
  FDA February 11, 2026 · Boston Scientific Corporation · Class I
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm recall
  FDA February 11, 2026 · Boston Scientific Corporation · Class I
• AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm recall
  FDA February 11, 2026 · Boston Scientific Corporation · Class I
• Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model recall
  FDA February 4, 2026 · SunMed Holdings, LLC · Class I
• Broselow Product Name: Broselow Domestic Complete ALS Organizer Model recall
  FDA February 4, 2026 · SunMed Holdings, LLC · Class I
• Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model recall
  FDA February 4, 2026 · SunMed Holdings, LLC · Class I
• Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model recall
  FDA February 4, 2026 · SunMed Holdings, LLC · Class I
• MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed recall
  FDA January 28, 2026 · Medline Industries, LP · Class I
• MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed recall
  FDA January 28, 2026 · Medline Industries, LP · Class I
• MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed recall
  FDA January 28, 2026 · Medline Industries, LP · Class I
• MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed recall
  FDA January 28, 2026 · Medline Industries, LP · Class I
• MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed recall
  FDA January 28, 2026 · Medline Industries, LP · Class I
• MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed recall
  FDA January 28, 2026 · Medline Industries, LP · Class I
• FreeStyle Libre 3 Plus Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• FreeStyle Libre 3 Plus Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• FreeStyle Libre 3 Plus Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• FreeStyle Libre 3 Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 recall
  FDA January 14, 2026 · AVID Medical, Inc. · Class I
• Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17 recall
  FDA January 14, 2026 · AVID Medical, Inc. · Class I
• Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15 recall
  FDA January 14, 2026 · AVID Medical, Inc. · Class I
• Alcon Laboratories, Inc recall
  FDA December 31, 2025 · Alcon Research LLC · Class I
• Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer recall
  FDA December 31, 2025 · Draeger, Inc. · Class I
• Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer recall
  FDA December 31, 2025 · Draeger, Inc. · Class I
• GE Healthcare Carestation anesthesia system Power Management Board (PMB)… recall
  FDA December 24, 2025 · GE Medical Systems China Co., Ltd. · Class I
• GE Healthcare Carestation anesthesia system, product number and recall
  FDA December 24, 2025 · GE Medical Systems China Co., Ltd. · Class I
• GE Healthcare Carestation anesthesia system, product number and recall
  FDA December 24, 2025 · GE Medical Systems China Co., Ltd. · Class I
• Ivenix Infusion System (IIS), LVP Software LVP-SW-0005… recall
  FDA December 24, 2025 · Fresenius Kabi USA, LLC · Class I
• ErgoStar CM 60, Model recall
  FDA December 17, 2025 · Draeger, Inc. · Class I
• ErgoStar CM 55, Model recall
  FDA December 17, 2025 · Draeger, Inc. · Class I
• ErgoStar CM 45, Model recall
  FDA December 17, 2025 · Draeger, Inc. · Class I
• ErgoStar CM 40 Model recall
  FDA December 17, 2025 · Draeger, Inc. · Class I
• IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet… recall
  FDA December 10, 2025 · Fresenius Kabi USA, LLC · Class I
• Single Use Ligating Device Product Name: Olympus HX-400U-30 Model recall
  FDA December 3, 2025 · Olympus Corporation of the Americas · Class I
• SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number recall
  FDA December 3, 2025 · Glycar SA Pty., Ltd. · Class I
• SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number recall
  FDA December 3, 2025 · Glycar SA Pty., Ltd. · Class I
• TMJ Bilateral Implant recall
  FDA November 26, 2025 · TMJ Solutions Inc · Class I