Class I medical devices recalls

FDA Class I recalls of medical devices, newest first. Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

734 recalls published between October 9, 2024 and September 30, 2026. Most common issues: sterility (74), software (73), injury risk (70), fall (23). 734 were FDA Class I, the most serious level.

• Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall
  FDA September 30, 2026 · Boston Scientific Corporation · Class I
• Halyard IV START KIT NON-STERILE recall
  FDA September 30, 2026 · AVID Medical, Inc. · Class I
• INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set recall
  FDA September 30, 2026 · CooperSurgical, Inc. · Class I
• INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recall
  FDA September 30, 2026 · CooperSurgical, Inc. · Class I
• Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall
  FDA September 23, 2026 · AVID Medical, Inc. · Class I
• Haylard BASIC BIOPSY TRAY recall
  FDA September 23, 2026 · AVID Medical, Inc. · Class I
• Haylard CONTINUOUS NERVE BLOCK TRAY recall
  FDA September 23, 2026 · AVID Medical, Inc. · Class I
• Haylard 18G SINGLE SHOT EPI TRAY recall
  FDA September 23, 2026 · AVID Medical, Inc. · Class I
• Impella Optical Controller, Automated Impella Controller… recall
  FDA September 23, 2026 · Abiomed, Inc. · Class I
• Impella Optical Controller with the below product descriptions and… recall
  FDA September 23, 2026 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC) with the below product descriptions and… recall
  FDA September 23, 2026 · Abiomed, Inc. · Class I
• StatStrip Glucose and B- Ketone meter recall
  FDA September 23, 2026 · Nova Biomedical Corporation · Class I
• StatStrip Glucose and B- Ketone meter recall
  FDA September 23, 2026 · Nova Biomedical Corporation · Class I
• StatStrip Glucose and B- Ketone meter recall
  FDA September 23, 2026 · Nova Biomedical Corporation · Class I
• StatStrip Glucose Hospital Meter System recall
  FDA September 23, 2026 · Nova Biomedical Corporation · Class I
• StatStrip Glucose Hospital Meter System recall
  FDA September 23, 2026 · Nova Biomedical Corporation · Class I
• Medline Convenience Kits: 1) DYNDB3086D recall
  FDA September 23, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) DYNDH1193 recall
  FDA September 23, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) DYKM1000B recall
  FDA September 23, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) ACC010308A recall
  FDA September 23, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA recall
  FDA September 23, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) OPEN HEART ADULT recall
  FDA September 23, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET recall
  FDA September 23, 2026 · Medline Industries, LP · Class I
• Halyard IV START KIT NON-STERILE recall
  FDA September 23, 2026 · AVID Medical, Inc. · Class I
• BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD… recall
  FDA September 23, 2026 · Bd Switzerland Sarl · Class I
• DuoGlide Short-Term Straight Dialysis Catheter recall
  FDA September 23, 2026 · Bard Access Systems, Inc. · Class I
• Power-Trialysis Short-Term Straight Dialysis Catheter recall
  FDA September 23, 2026 · Bard Access Systems, Inc. · Class I
• Kit: Single Shot Epidural 20/Cs recall
  FDA September 16, 2026 · Medical Action Industries, Inc. 306 · Class I
• Kit: Epidural/Pain TQC 20/Cs recall
  FDA September 16, 2026 · Medical Action Industries, Inc. 306 · Class I
• Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635… recall
  FDA September 16, 2026 · Given Imaging Ltd. · Class I
• BMC/REACTHEALTH Luna G3 APAP recall
  FDA August 26, 2026 · BMC Medical Co., Ltd. · Class I
• Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus… recall
  FDA August 26, 2026 · Boston Scientific Corporation · Class I
• Boston Scientific ENROUTE Transcarotid Neuroprotection System… recall
  FDA August 26, 2026 · Boston Scientific Corporation · Class I
• BD Needle Kit for Powered Driver 15mm x 15Ga recall
  FDA August 26, 2026 · Bard Access Systems, Inc. · Class I
• Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection… recall
  FDA August 19, 2026 · Spectra Medical Devices, Llc · Class I
• Baxter Duo-Vent Solution Set and Male Luer Lock Adapter… recall
  FDA August 19, 2026 · Baxter Healthcare Corporation · Class I
• INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500 recall
  FDA August 12, 2026 · Boston Scientific Neuromodulation Corporation · Class I
• Halyard convenience kits containing recalled Medline Namic Angiographic… recall
  FDA August 12, 2026 · AVID Medical, Inc. · Class I
• Halyard convenience kits containing recalled Medline Namic Angiographic… recall
  FDA August 12, 2026 · AVID Medical, Inc. · Class I
• Halyard convenience kits containing recalled Medline Namic Angiographic… recall
  FDA August 12, 2026 · AVID Medical, Inc. · Class I
• Pack Angiography NCMC 3/Cs BANNER recall
  FDA August 5, 2026 · Medical Action Industries, Inc. 306 · Class I
• Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that… recall
  FDA August 5, 2026 · ResMed Ltd. · Class I
• MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF… recall
  FDA July 29, 2026 · Medline Industries, LP · Class I
• MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF… recall
  FDA July 29, 2026 · Medline Industries, LP · Class I
• MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT… recall
  FDA July 29, 2026 · Medline Industries, LP · Class I
• MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835 recall
  FDA July 29, 2026 · Medline Industries, LP · Class I
• MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G recall
  FDA July 29, 2026 · Medline Industries, LP · Class I
• Bone Marrow Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• Arterial Line Kit 20ga x 6 recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• T-Lok Bone Marrow Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• General Biospy Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• One-Piece Introducer Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0044 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0014 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I