Medical devices recalls

Medical device recalls from FDA enforcement reports, from surgical kits to imaging systems and software issues.

5,876 recalls published between October 9, 2024 and September 30, 2026. Most common issues: sterility (843), software (360), injury risk (241), microbial contamination (195). 734 were FDA Class I, the most serious level.

• Medline Convenience Kits: 1) ANTERIOR SPINE PACK recall
  FDA September 30, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) MAJOR NEURO VCH recall
  FDA September 30, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) MFC CRANIOTOMY PACK recall
  FDA September 30, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) MAJOR PACK recall
  FDA September 30, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) PEDS SINUS PACK recall
  FDA September 30, 2026 · Medline Industries, LP · Class II
• PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT)… recall
  FDA September 30, 2026 · Baxter Healthcare Corporation · Class II
• PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT)… recall
  FDA September 30, 2026 · Baxter Healthcare Corporation · Class II
• PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate… recall
  FDA September 30, 2026 · Baxter Healthcare Corporation · Class II
• Halyard IV START KIT NON-STERILE recall
  FDA September 30, 2026 · AVID Medical, Inc. · Class II
• Halyard IV START KIT NON-STERILE recall
  FDA September 30, 2026 · AVID Medical, Inc. · Class II
• New York Embroidery Studio Trinity Non-Surgical Isolation Gown… recall
  FDA September 30, 2026 · New York Embroidery Studio, Inc. · Class II
• Cardioroot Woven Collagen Coated Vascular Graft recall
  FDA September 30, 2026 · Intervascular, Sas · Class II
• VOLARA System Product Name: VOLARA, HC, NA A Model recall
  FDA September 30, 2026 · Baxter Healthcare Corporation · Class II
• REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recall
  FDA September 30, 2026 · DeRoyal Industries Inc · Class II
• Presource Convenience Kits: 1) KIT, USGPIV recall
  FDA September 30, 2026 · Cardinal Health 200, LLC · Class II
• Presource Convenience Kits: 1) KIT, PRE OP recall
  FDA September 30, 2026 · Cardinal Health 200, LLC · Class II
• nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US… recall
  FDA September 30, 2026 · Criticare Technologies, Inc. · Class II
• Automated Impella Controller (AIC) with the below product descriptions and… recall
  FDA September 30, 2026 · Abiomed, Inc. · Class II
• ForeSight Elite Tissue Oximetry Cable recall
  FDA September 30, 2026 · Becton Dickinson & Co. · Class II
• Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall
  FDA September 30, 2026 · Philips Ultrasound, Inc · Class II
• Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model recall
  FDA September 30, 2026 · CooperVision, Inc. · Class II
• Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T… recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• MR 7700 and Upgrade to MR 7700 recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• MR 5300 Model Number ( recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3… recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Ingenia Elition S and Ingenia Elition X recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Ingenia 3.0T and Ingenia 3.0T CX recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Ingenia Ambition S and Ingenia Ambition X recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Evolution upgrade 1.5T and Evolution upgrade 3.0T recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Achieva XR recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Achieva 3.0T recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system recall
  FDA September 30, 2026 · Philips North America Llc · Class II
• VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING -… recall
  FDA September 30, 2026 · Biomerieux Inc · Class II
• Medline convenience kits containing Healthmark Instrument Channel Brushes recall
  FDA September 30, 2026 · Medline Industries, LP · Class II
• Medline convenience kits containing Healthmark Instrument Channel Brushes recall
  FDA September 30, 2026 · Medline Industries, LP · Class II
• SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head… recall
  FDA September 30, 2026 · Seaspine Orthopedics Corporation · Class II
• CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and… recall
  FDA September 30, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3… recall
  FDA September 30, 2026 · Maquet SAS · Class II
• REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870… recall
  FDA September 30, 2026 · Ventec Life Systems, Inc. · Class II
• REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated… recall
  FDA September 30, 2026 · Ventec Life Systems, Inc. · Class II
• HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870… recall
  FDA September 30, 2026 · Ventec Life Systems, Inc. · Class II
• Midmark IQvitals Zone, automatically and noninvasively measures systolic… recall
  FDA September 30, 2026 · Midmark Corporation · Class II
• Midmark IQvitals Zone, automatically and noninvasively measures systolic… recall
  FDA September 30, 2026 · Midmark Corporation · Class II
• Midmark IQvitals Zone, automatically and noninvasively measures systolic… recall
  FDA September 30, 2026 · Midmark Corporation · Class II
• Midmark IQvitals Zone, automatically and noninvasively measures systolic… recall
  FDA September 30, 2026 · Midmark Corporation · Class II
• Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm recall
  FDA September 30, 2026 · Olympus Corporation of the Americas · Class II
• Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model recall
  FDA September 30, 2026 · Heidelberg Engineering GmbH · Class II
• 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
• Pi-Cardia Inc recall
  FDA September 23, 2026 · Pi Cardia Ltd · Class II
• CADD Yellow Medication Cassette Reservoir with NRFit connector US Product… recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Reign Medical Clench Staple System (Compression), Description recall
  FDA September 23, 2026 · F & A Foundation · Class II
• Convenience kits CATARACT PACK DYNJ59881A recall
  FDA September 23, 2026 · Medline Industries, LP · Class II