Class II medical devices recalls – page 15

• Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0… recall
  FDA June 10, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Philips Azurion 3M15, Model Numbers: 722064… recall
  FDA June 10, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Philips Azurion 3M12, Model Numbers: 722063… recall
  FDA June 10, 2026 · Philips Medical Systems Nederland B.V. · Class II
• HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus… recall
  FDA June 10, 2026 · Advanced Bionics, LLC · Class II
• Neptune Smart Docking Station (120V) recall
  FDA June 10, 2026 · Stryker Corporation · Class II
• Covidien EndoStitch" Polysorb Single Use Loading Unit recall
  FDA June 10, 2026 · Covidien, LP · Class II
• CASE v7.0 Cardiac Testing System Model no recall
  FDA June 10, 2026 · GE Medical Systems Information Technologies Inc · Class II
• PhaseOne Antimicrobial Solution, Model recall
  FDA June 10, 2026 · Oculus Technologies of Mexico, S.A. de C.V. · Class II
• The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall
  FDA June 10, 2026 · Fresenius Kabi USA, LLC · Class II
• Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr recall
  FDA June 10, 2026 · Covidien, LP · Class II
• Covidien Mon-a-Therm General Purpose Temperature Probe recall
  FDA June 10, 2026 · Covidien, LP · Class II
• Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM recall
  FDA June 10, 2026 · Covidien, LP · Class II
• B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID… recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP… recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model recall
  FDA June 10, 2026 · B Braun Medical Inc · Class II
• Exacta Mix Product Name: Vented Micro-Volume Inlet Model recall
  FDA June 10, 2026 · Baxter Healthcare Corporation · Class II
• COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula recall
  FDA June 10, 2026 · Covidien, LP · Class II
• ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model… recall
  FDA June 10, 2026 · Siemens Medical Solutions USA, Inc · Class II
• ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system recall
  FDA June 10, 2026 · Siemens Medical Solutions USA, Inc · Class II
• Medline medical convenience kit labeled as EYE TRAY-LF… recall
  FDA June 3, 2026 · Medline Industries, LP · Class II
• Allura system recall
  FDA June 3, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Azurion system recall
  FDA June 3, 2026 · Philips Medical Systems Nederland B.V. · Class II
• GE HealthCare ApexPro v6.0 eDelivery Software recall
  FDA June 3, 2026 · GE Medical Systems Information Technologies Inc · Class II
• GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA recall
  FDA June 3, 2026 · GE Medical Systems Information Technologies Inc · Class II
• GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA recall
  FDA June 3, 2026 · GE Medical Systems Information Technologies Inc · Class II
• GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER recall
  FDA June 3, 2026 · GE Medical Systems Information Technologies Inc · Class II
• GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit… recall
  FDA June 3, 2026 · GE Medical Systems Information Technologies Inc · Class II
• GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL recall
  FDA June 3, 2026 · GE Medical Systems Information Technologies Inc · Class II
• Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002 recall
  FDA June 3, 2026 · Medtronic Neuromodulation · Class II
• Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001 recall
  FDA June 3, 2026 · Medtronic Neuromodulation · Class II
• HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 recall
  FDA June 3, 2026 · Devicor Medical Products Inc · Class II
• Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771… recall
  FDA June 3, 2026 · O&M Halyard, Inc. · Class II
• Integris-Allura system recall
  FDA May 27, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura system recall
  FDA May 27, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Azurion system recall
  FDA May 27, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Silastic Foley Catheters Silastic Brand Foley Catheter 30cc recall
  FDA May 27, 2026 · C.R. Bard Inc · Class II
• Philips Azurion systems not configured with an optional auxiliary pan… recall
  FDA May 27, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR… recall
  FDA May 27, 2026 · Medtronic Perfusion Systems · Class II
• OneLIF Interbody Cage ( recall
  FDA May 27, 2026 · Novapproach Spine, LLC · Class II
• Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock… recall
  FDA May 27, 2026 · ICU Medical, Inc. · Class II
• Tangent Endoscopy, Tangent Single Use Digital Catheter recall
  FDA May 27, 2026 · Tangent Endoscopy, LLC · Class II
• Swan-Ganz Pacing Catheter, Models: D200F7 recall
  FDA May 27, 2026 · Becton Dickinson & Co. · Class II
• Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P recall
  FDA May 27, 2026 · Becton Dickinson & Co. · Class II
• Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75… recall
  FDA May 27, 2026 · Becton Dickinson & Co. · Class II
• Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer… recall
  FDA May 20, 2026 · Medtronic Neuromodulation · Class II
• LVIS Intraluminal Support Device recall
  FDA May 20, 2026 · Microvention Inc. · Class II
• Medtronic Marinr Steerable, Product Number 72402 recall
  FDA May 20, 2026 · Stryker Sustainability Solutions · Class II