Class I medical devices recalls – page 9

• FEM-FLEXII Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• FEM-FLEX II Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• FEM-FLEX II Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• FEM-FLEX II Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• Bravo CF capsule delivery device, designed to place and attach a pH… recall
  FDA July 16, 2025 · Given Imaging Ltd. · Class I
• Hillrom LikoScale component, Product Code 3156232… recall
  FDA July 16, 2025 · Baxter Healthcare Corporation · Class I
• Hillrom Q-Link 13 component, Product Code 3156509… recall
  FDA July 16, 2025 · Baxter Healthcare Corporation · Class I
• BiPAP A40 Ventilator recall
  FDA July 9, 2025 · Philips Respironics, Inc. · Class I
• BiPAP A30 Ventilators recall
  FDA July 9, 2025 · Philips Respironics, Inc. · Class I
• BiPAP V30 Auto Ventilator recall
  FDA July 9, 2025 · Philips Respironics, Inc. · Class I
• Servo-u MR Ventilator System recall
  FDA July 9, 2025 · Maquet Critical Care AB · Class I
• Servo-n Ventilator System recall
  FDA July 9, 2025 · Maquet Critical Care AB · Class I
• Servo-u Ventilator System recall
  FDA July 9, 2025 · Maquet Critical Care AB · Class I
• MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and… recall
  FDA July 2, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• Extended Tip Applicator 8CM, Box of 1 recall
  FDA July 2, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• Extended Tip Applicator, 15 CM, Box of 5 recall
  FDA July 2, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• Extended Tip Applicator, 8CM, Box of 5 recall
  FDA July 2, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) recall
  FDA July 2, 2025 · SunMed Holdings, LLC · Class I
• Dexcom One Continuous Glucose Monitoring System… recall
  FDA June 25, 2025 · Dexcom, Inc. · Class I
• Dexcom One+ Continuous Glucose Monitoring System… recall
  FDA June 25, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0)… recall
  FDA June 25, 2025 · Dexcom, Inc. · Class I
• Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) &… recall
  FDA June 25, 2025 · Dexcom, Inc. · Class I
• Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate… recall
  FDA June 25, 2025 · Cook Incorporated · Class I
• Newport HT70 Ventilator recall
  FDA June 18, 2025 · Covidien, LP · Class I
• IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet… recall
  FDA June 18, 2025 · Fresenius Kabi USA, LLC · Class I
• Z-800WF Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• Z-800W Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• Z-800F Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• Z-800 Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter… recall
  FDA June 11, 2025 · SunMed Holdings, LLC · Class I
• Medline Kits containing Codman Disposable Perforator 14 mm: 1… recall
  FDA June 11, 2025 · Medline Industries, LP · Class I
• Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY… recall
  FDA June 11, 2025 · Medline Industries, LP · Class I
• Medline Kits containing Codman Disposable Perforator 14 mm: 1… recall
  FDA June 11, 2025 · Medline Industries, LP · Class I
• Baxter Novum IQ LVP INFUSION SYSTEM recall
  FDA May 28, 2025 · Baxter Healthcare Corporation · Class I
• Centerline Biomedical IOPS Guidewire 2 recall
  FDA May 28, 2025 · Centerline Biomedical Inc · Class I
• Bard¿ Single Intragastric Linton Balloon Tube recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate) recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard Blakemore Esophageal-Nasogastric Tube (Adult) recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard Minnesota Four Lumen Esophagogastric Tamponade Tube recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm… recall
  FDA May 28, 2025 · Ethicon Endo Surgery, LLC · Class I
• MedicaLyte Liquid Bicarbonate Concentrate recall
  FDA May 21, 2025 · Nipro Renal Soultions USA, Corporation · Class I
• iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator… recall
  FDA May 21, 2025 · Medical Depot Inc. · Class I
• Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004 recall
  FDA May 21, 2025 · Baxter Healthcare Corporation · Class I
• Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002 recall
  FDA May 21, 2025 · Baxter Healthcare Corporation · Class I
• AirLife Product Name: AirLife Infant Heated Wire Circuit Model recall
  FDA May 21, 2025 · Vyaire Medical · Class I
• AirLife Product Name: AirLife Infant Heated Wire Circuit Model recall
  FDA May 21, 2025 · Vyaire Medical · Class I
• CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill… recall
  FDA May 14, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• CODMAN Disposable Perforator, 14mm recall
  FDA May 14, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT… recall
  FDA May 14, 2025 · Smiths Medical ASD, Inc. · Class I
• CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2… recall
  FDA May 14, 2025 · Smiths Medical ASD, Inc. · Class I
• Intraocular Lens recall
  FDA May 14, 2025 · Bausch & Lomb Surgical, Inc. · Class I
• Intraocular lens recall
  FDA May 14, 2025 · Bausch & Lomb Surgical, Inc. · Class I
• CADD-Solis VIP Ambulatory Infusion Pump recall
  FDA May 14, 2025 · Smiths Medical ASD, Inc. · Class I
• CADD-Solis HPCA Ambulatory Infusion Pump recall
  FDA May 14, 2025 · Smiths Medical ASD, Inc. · Class I
• CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply… recall
  FDA May 14, 2025 · Smiths Medical ASD, Inc. · Class I
• GE Healthcare CARESTATION 750c A2, Model recall
  FDA May 7, 2025 · GE Medical Systems China Co., Ltd. · Class I
• GE Healthcare CARESTATION 750c A1, Model recall
  FDA May 7, 2025 · GE Medical Systems China Co., Ltd. · Class I