Medical devices recalls – page 65

• 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
• Spectral CT. Computed tomography X-ray system recall
  FDA July 2, 2025 · Philips North America Llc · Class II
• Jewel Precision Reusable Rigid Sterilization Container System recall
  FDA July 2, 2025 · Jewel Precision Sheet Metal & Machining Co, Inc. · Class II
• GE Healthcare Versana Ultrasound Systems, sold under the following names… recall
  FDA July 2, 2025 · GE Medical Systems China Co., Ltd. · Class II
• GE Healthcare LOGIQ F R3 Ultrasound System, Model recall
  FDA July 2, 2025 · GE Medical Systems China Co., Ltd. · Class II
• REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487 recall
  FDA July 2, 2025 · Beckman Coulter, Inc. · Class II
• Atellica CH Diluent - CONS 2 x 1.5L recall
  FDA July 2, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Jewel Precision Reusable Rigid Sterilization Container System recall
  FDA July 2, 2025 · Jewel Precision Sheet Metal & Machining Co, Inc. · Class II
• PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW recall
  FDA July 2, 2025 · Limacorporate S.p.A · Class II
• PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW recall
  FDA July 2, 2025 · Limacorporate S.p.A · Class II
• BD BACTEC MGIT 960 PZA Kit recall
  FDA July 2, 2025 · Becton Dickinson & Co. · Class II
• CDI OneView System BPM Probe: Cat recall
  FDA July 2, 2025 · Terumo Cardiovascular Systems Corporation · Class II
• Product Name [ recall
  FDA July 2, 2025 · CareFusion 303, Inc. · Class II
• Omnipod 5 Automated Insulin Delivery System, iOS Application recall
  FDA July 2, 2025 · Insulet Corporation · Class II
• Caphosol Artificial Saliva (32 doses sachet box) recall
  FDA July 2, 2025 · Recordati Rare Diseases Inc. · Class II
• ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW… recall
  FDA July 2, 2025 · Encore Medical, LP · Class II
• ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW… recall
  FDA July 2, 2025 · Encore Medical, LP · Class II
• ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW… recall
  FDA July 2, 2025 · Encore Medical, LP · Class II
• ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW… recall
  FDA July 2, 2025 · Encore Medical, LP · Class II
• REF: 381434 BD Insyte Autoguard Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 382544 BD Insyte Autoguard Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381433, BD Insyte Autoguard Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 382633, BD Insyte Autoguard BC Winged… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381423, BD Insyte Autoguard, Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for… recall
  FDA July 2, 2025 · Jolife AB · Class II
• Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1… recall
  FDA July 2, 2025 · Bigfoot Biomedical · Class II
• DxI 9000 Access Immunoassay Analyzer C11137 recall
  FDA July 2, 2025 · Beckman Coulter, Inc. · Class II
• Medline UMBILICAL TRAY W/3.5&5FR CATH recall
  FDA July 2, 2025 · Medline Industries, LP · Class II
• Model: Description recall
  FDA July 2, 2025 · Barco N.V. · Class II
• 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
• STA - Owren Koller recall
  FDA June 25, 2025 · Diagnostica Stago, Inc. · Class II
• 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case… recall
  FDA June 25, 2025 · Fresenius Medical Care Holdings, Inc. · Class II
• ICU Medical Plum Solos, Item number 400011001 recall
  FDA June 25, 2025 · ICU Medical, Inc. · Class II
• ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001… recall
  FDA June 25, 2025 · ICU Medical, Inc. · Class II
• Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311… recall
  FDA June 25, 2025 · Balt USA, LLC · Class II
• Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875… recall
  FDA June 25, 2025 · Balt USA, LLC · Class II
• Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment recall
  FDA June 25, 2025 · Preat Corp · Class II
• SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone… recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• UROSKOP Omnia Max recall
  FDA June 25, 2025 · Siemens Medical Solutions USA, Inc · Class II
• UROSKOP Omnia recall
  FDA June 25, 2025 · Siemens Medical Solutions USA, Inc · Class II
• GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S recall
  FDA June 25, 2025 · Ohio Medical Corporation · Class II
• Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing… recall
  FDA June 25, 2025 · Guangzhou Pluslife Biotech Co., Ltd. · Class II
• MiniDock Product Name: Integrated Nucleic Acid Testing Device Model recall
  FDA June 25, 2025 · Guangzhou Pluslife Biotech Co., Ltd. · Class II
• REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recall
  FDA June 25, 2025 · Orthofix Srl · Class II
• AcoSound recall
  FDA June 25, 2025 · Hangzhou Acosound Technology CO., Ltd. · Class III
• 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